Food Intake RegulationHITSNCT07082582
Investigating in Humans the Impact of Training Status on Dietary Consumption With Direct Measurement of Ingestive Behaviour
An observational study of Food Intake Regulation and Training Status, run by Michele Serra at 1 site in Switzerland.
Trial summary
The goal of the research project is to investigate the influence of training status on ingestive behavior and postprandial physiological responses in the human body. The investigators aim to understand how regular training influences the choice and amount of food consumed, as well as the associated physiological… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Intake Regulation, Training Status
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants in the trained group are recruited from a rowing club affiliated with the University of Zürich (UZH) and Federal Technical institute of Zürich (ETH). Participants in the untrained group are recruited from students and employees of UZH and ETH.
Who may be able to join
- Training status classified as "trained" or "untrained",
- Chronological age ≥ 18 and ≤ 35,
- Body Mass Index ≥ 18.5 and ≤ 26,
- Current enrolment in a university,
- Language: English or German, with a sufficient English proficiency to fill out the food questionnaire,
- Ability and willingness to participate in the study, and
- Voluntarily signed informed consent.
Who cannot join
- History of previous metabolic and bariatric surgery,
- Current use of medications for medical treatment (excluding contraceptive measures),
- Current use of over-the-counter medications for weight loss or appetite control,
- Current medical diagnosis of metabolic disorders (such as type
- 1 or 2 diabetes mellitus),
- Use of antibiotics in the last two months,
Show all 12Show fewer
- History of use of probiotics (excluding yogurt and sauerkraut),
- Smoking,
- Biological or surgical menopause,
- Polycystic ovary syndrome (PCOS),
- Pregnancy, lactation, or current attempt of conception, and
- History of chronic substance abuse.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
The goal of the research project is to investigate the influence of training status on ingestive behavior and postprandial physiological responses in the human body. The investigators aim to understand how regular training influences the choice and amount of food consumed, as well as the associated physiological processes, including changes in the spectrum of gut hormones. The investigators are particularly interested in how these factors differ between individuals who train regularly compared to those who do not follow a structured training program.
The research project aims to translate findings from previous animal experiments to humans and to examine whether and how training affects food handling and physiological responses, similar to observations made in rodents. This information could significantly contribute to improving recommendations for diet and physical activity in the population.
Read the detailed description
The goal of the proposed research is to identify the differences in ingestive behavior that might be caused by the training status in humans after long-term structured exercise. For this, the investigators plan to investigate and cross-sectionally compare microstructural parameters of ingestive behavior between individuals with trained and untrained status when offered three different meals (high-carbohydrate, high-fat, high-sucrose lactose-free milk) separately or concurrently.
Furthermore, the investigators propose to explore a possible correlation between microstructural parameters of ingestive behavior and postprandial levels of several gut hormones, and to investigate the differences in the composition and activity of the gut microbiome between the two groups, especially in relation to the observed ingestive behavior. Finally, the investigators will investigate the relationship between ingestive behavior and body composition separately for the two groups.
The microstructure of ingestive behavior of both male and female individuals in relation to training status has never been investigated in a direct measurement approach before and the investigators of this project are the only one that currently have both the technical requirements as well as the necessary experience to carry out such studies.
The previous research project "Direct measurement of changes in food selection and intake behavior after RYGB surgery" (NCT04933305, NCT03747445) was successful. Although recruitment and retention of study participants was significantly hindered by the COVID-19 pandemic after March 2020, the investigators were able to publish four peer-reviewed scientific articles out of the proposed studies so far. Four additional manuscripts are currently in preparation.
The present research project builds logically on previous work in the field of bariatric surgery and builds a new collaborations with Prof. J. Nicholas Betley and Dr. Lavinia Boccia (University of Pennsylvania, USA). This collaboration will surely lead to relevant findings which will be published in at least two peer-reviewed publications.
- Conditions
- Food Intake Regulation, Training Status
- Keywords
- Ingestive behavior, Gut Hormones, Drinkometer
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with trained Status | Trained status: continuous participation in a structured training program for at least the past six months, in addition to meeting the minimum requirement of physical activity of 150 min of moderate physical activity or 75 min of vigorous physical activity per week. | |
| Participants with untrained Status | Untrained status: No participation in any structured training program for the last six months, in addition to not performing physical activity above 150 min of moderate physical activity or 75 min of vigorous physical activity per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Intake from Liquid Meal Consumption
Total energy intake (in kilocalories) from consumption of high-carbohydrate, high-sucrose, and high-fat lactose-free milk during each visit. Intake is measured using a drinkometer device that quantifies the exact volume consumed, which is then converted into kilocalories based on the known energy density of each meal type. The unit of measure is kilocalories (kcal).
Measured: From enrolment to the end of the study participation through four study visits within three months.
Macrostructure of Ingestive Behavior (Rate of Energy Intake)
The rate of energy intake is calculated for each participant during the ingestion of each of the three test stimuli, based on standardized measurements from the drinkometer system. This measure reflects the average caloric intake per second over the course of the test stimulus consumption. Energy intake is determined by the volume of liquid consumed, multiplied by the known caloric density of the test stimulus, and divided by the duration of the ingestion period. The unit of measure is kilocalories per second (kcal/s).
This outcome is assessed during the first three study visits, in which a single test stimulus is administered at each visit. It is not measured during the fourth study visit, where all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months
Macrostructure of Ingestive Behavior (Meal Duration)
Meal duration is defined as the total time taken by each participant to consume each of the three test stimuli, measured using the standardized drinkometer system. For each stimulus, the duration is recorded from the initiation of ingestion (first measurable suck) to the completion of consumption (last measurable suck). The unit of measure is seconds (s).
This outcome is assessed during the first three study visits, each involving the administration of a single test stimulus. Meal duration is not measured during the fourth study visit, where all three test stimuli are offered to participants simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Macrostructure of Ingestive Behavior (Number of Sucks)
The primary outcome is the number of sucks performed by each participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "suck" is defined as a discrete negative pressure event generated by the participant to draw in liquid, as detected by the drinkometer's calibrated weight sensors. For each stimulus, the total number of sucks is recorded as a simple count, with the unit of measure being "number (n)." The outcome is assessed during the first three study visits, each of which features a single test stimulus administered in a standardized fashion. This outcome is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously to the participant.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Suck Energy Intake)
Suck energy intake is defined as the total amount of energy (in kilocalories) consumed by the participant during each individual suck, measured for each of the three test stimuli using a standardized drinkometer system. For each test stimulus, the total caloric intake is calculated by multiplying the volume of liquid ingested by its caloric density and summing the values across all measured sucks. The unit of measure is kilocalories (kcal).
This outcome is assessed during the first three study visits, where each visit involves a single test stimulus. Suck energy intake is not measured during the fourth study visit, in which all three test stimuli are presented to the participant simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Suck Duration)
Suck duration is defined as the time span of each individual suck performed by the participant during the ingestion of each of the three test stimuli, as measured by a standardized drinkometer system. For each test stimulus, the duration of every suck is recorded from the initiation to the completion of the negative pressure event. The unit of measure is seconds (s).
This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Suck duration is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Suck Rate)
Suck rate is defined as the average energy intake of liquid ingested per second during each individual suck, measured for each of the three test stimuli using a standardized drinkometer system. For each test stimulus, the energy intake consumed during each suck is divided by the corresponding suck duration to determine the rate of ingestion for that event. The unit of measure is kilocalories per second (kcal/s).
This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Suck rate is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Suck Maximal Rate)
Suck maximal rate is defined as the highest instantaneous rate of liquid ingestion (in kilocalories per second) achieved during any single suck by the participant for each of the three test stimuli, as measured using a standardized drinkometer system. For each test stimulus, the maximal rate is determined by identifying the suck with the greatest energy intake per unit time among all measured sucks during the ingestion period. The unit of measure is kilocalories per second (kcal/s).
This outcome is assessed during the first three study visits, with each visit involving a single test stimulus. Suck maximal rate is not measured during the fourth study visit, where all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Burst Number)
Burst number is defined as the total count of distinct bursts performed by the participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of successive sucks separated by brief pauses, typically reflecting a rhythmic drinking pattern. For each test stimulus, the number of such bursts is recorded as an integer value. The unit of measure is "number of bursts" (n).
This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Burst number is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Burst Duration)
Burst duration is defined as the total elapsed time of each individual burst performed by the participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the duration is measured from the onset of the first suck to the end of the last suck within the burst. The unit of measure is seconds (s).
This outcome is assessed during the first three study visits, with each visit involving a single test stimulus. Burst duration is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Burst Energy Intake)
Burst energy intake is defined as the total amount of energy intake (in kilocalories) consumed during each individual burst by the participant, measured for each of the three test stimuli using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the energy intake is calculated by multiplying the volume of liquid ingested within the burst by the energy density of the test stimulus. The unit of measure is kilocalories (kcal).
This outcome is assessed during the first three study visits, each involving a single test stimulus. Burst size is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Burst Rate)
Burst rate is defined as the average rate of energy intake during each individual burst performed by the participant for each of the three test stimuli, as measured using a standardized drinkometer system. For each burst, the total energy intake (in kilocalories) is divided by the duration of the burst (in seconds) to determine the average rate of energy intake for that burst. The unit of measure is kilocalories per second (kcal/s).
This outcome is assessed during the first three study visits, each involving a single test stimulus. Burst rate is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Number of Sucks per Burst)
Number of sucks per burst is defined as the average count of individual sucks occurring within each burst during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the total number of sucks is recorded, and the outcome is typically reported as the mean number of sucks per burst. The unit of measure is "number of sucks per burst" (n).
This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Number of sucks per burst is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Inter-Burst Intervals)
Inter-burst interval is defined as the elapsed time between the end of one burst and the onset of the subsequent burst during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. The inter-burst interval quantifies the temporal spacing between bursts and is recorded in seconds (s).
This outcome is assessed during the first three study visits, each involving a single test stimulus. Inter-burst intervals are not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Microstructure of Ingestive Behavior (Inter-Sucks Intervals)
Inter-suck interval is defined as the elapsed time between the end of one suck and the initiation of the subsequent suck during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "suck" is operationally defined as a discrete negative pressure event corresponding to the drawing in of liquid. The inter-suck interval quantifies the temporal spacing between individual sucks within a burst or throughout the test stimulus consumption, and is recorded in seconds (s).
This outcome is assessed during the first three study visits, each involving a single test stimulus. Inter-suck intervals are not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Measured: From enrolment to the end of the study participation through three of four study visits within three months.
Secondary outcomes (17)
Plasma GLP-1 Concentration
Change in GLP-1 concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma GIP Concentration
Change in GIP concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Amylin Concentration
Change in amylin concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma PYY Concentration
Change in PYY concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Ghrelin Concentration
Change in ghrelin concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Leptin Concentration
Change in leptin concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Insulin Concentration
Change in insulin concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma CCK Concentration
Change in CCK concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Glucagon Concentration
Change in glucagon concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Serotonin Concentration
Change in serotonin concentration (pmol/L) from pre-drink to post-drink (immediately and 30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Hunger
Self-reported hunger rated on a 100-mm visual analogue scale (VAS). Unit of Measure: millimeters (mm).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Fullness
Self-reported fullness rated on a 100-mm visual analogue scale (VAS). Unit of Measure: millimeters (mm).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Desire To Eat
Self-reported desire to eat rated on a 100-mm visual analogue scale (VAS). Unit of Measure: millimeters (mm).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Nausea
Self-reported nausea rated on a 100-mm visual analogue scale (VAS). Unit of Measure: millimeters (mm).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Abdominal Discomfort
Self-reported abdominal discomfort rated on a 100-mm visual analogue scale (VAS).
Unit of Measure: millimeters (mm).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Gut Microbiome Composition (Alpha and Beta Diversity)
Microbiome diversity is measured via 16S rRNA sequencing of stool samples collected at two distinct circadian time points: one sample in the morning and one in the late afternoon. The unit of measure is the Shannon index for alpha diversity and the UniFrac distance for beta diversity. While participants are instructed to collect samples at these specific times to capture circadian variation, the exact time of collection is dependent on each participant's individual bowel movement patterns and may vary accordingly.
Measured: Up to 14 days after study enrollment (microbiome diversity measured from two stool samples per participant: one in the morning, after afternoon; timing based on participant's natural bowel movement occurrence)
Gut Microbiome Functional Activity (Metabolite Analysis)
Quantification of microbial metabolites in stool samples. The unit of measure is micromoles per gram stool (µmol/g).
Measured: Up to 14 days after study enrollment (microbiome diversity measured from two stool samples per participant: one in the morning, after afternoon; timing based on participant's natural bowel movement occurrence)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start29 Oct 2024
- Primary completion31 Jul 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Food Intake RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michele Serra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor-investigator, Michele Serra, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082582
- Sponsor's protocol ID
- 2024-00926
- Acronym
- HITS
- Status last verified
- May 2026
- First submitted
- 17 Jun 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zouhal H, Sellami M, Saeidi A, Slimani M, Abbassi-Daloii A, Khodamoradi A, El Hage R, Hackney AC, Ben Abderrahman A. Effect of physical exercise and training on gastrointestinal hormones in populations with different weight statuses. Nutr Rev. 2019 Jul 1;77(7):455-477. doi: 10.1093/nutrit/nuz005.
PubMed 31125091Strasser B, Wolters M, Weyh C, Kruger K, Ticinesi A. The Effects of Lifestyle and Diet on Gut Microbiota Composition, Inflammation and Muscle Performance in Our Aging Society. Nutrients. 2021 Jun 15;13(6):2045. doi: 10.3390/nu13062045.
PubMed 34203776Sondergaard Nielsen M, Rasmussen S, Just Christensen B, Ritz C, le Roux CW, Berg Schmidt J, Sjodin A. Bariatric Surgery Does Not Affect Food Preferences, but Individual Changes in Food Preferences May Predict Weight Loss. Obesity (Silver Spring). 2018 Dec;26(12):1879-1887. doi: 10.1002/oby.22272. Epub 2018 Nov 13.
PubMed 30421858Serra M, File B, Alceste D, Raguz I, Gero D, Thalheimer A, Widmer J, Ismaeil A, Steinert RE, Spector AC, Bueter M. Burst-pause criterion derivation for drinkometer measurements of ingestive behavior. MethodsX. 2022 May 11;9:101726. doi: 10.1016/j.mex.2022.101726. eCollection 2022.
PubMed 35620756Quiroga R, Nistal E, Estebanez B, Porras D, Juarez-Fernandez M, Martinez-Florez S, Garcia-Mediavilla MV, de Paz JA, Gonzalez-Gallego J, Sanchez-Campos S, Cuevas MJ. Exercise training modulates the gut microbiota profile and impairs inflammatory signaling pathways in obese children. Exp Mol Med. 2020 Jul;52(7):1048-1061. doi: 10.1038/s12276-020-0459-0. Epub 2020 Jul 6.
PubMed 32624568Nielsen MS, Christensen BJ, Ritz C, Rasmussen S, Hansen TT, Bredie WLP, le Roux CW, Sjodin A, Schmidt JB. Roux-En-Y Gastric Bypass and Sleeve Gastrectomy Does Not Affect Food Preferences When Assessed by an Ad libitum Buffet Meal. Obes Surg. 2017 Oct;27(10):2599-2605. doi: 10.1007/s11695-017-2678-6.
PubMed 28411313Moody L, Liang J, Choi PP, Moran TH, Liang NC. Wheel running decreases palatable diet preference in Sprague-Dawley rats. Physiol Behav. 2015 Oct 15;150:53-63. doi: 10.1016/j.physbeh.2015.03.019. Epub 2015 Mar 16.
PubMed 25791204Monda V, Villano I, Messina A, Valenzano A, Esposito T, Moscatelli F, Viggiano A, Cibelli G, Chieffi S, Monda M, Messina G. Exercise Modifies the Gut Microbiota with Positive Health Effects. Oxid Med Cell Longev. 2017;2017:3831972. doi: 10.1155/2017/3831972. Epub 2017 Mar 5.
PubMed 28357027Mathes CM, Spector AC. Food selection and taste changes in humans after Roux-en-Y gastric bypass surgery: a direct-measures approach. Physiol Behav. 2012 Nov 5;107(4):476-83. doi: 10.1016/j.physbeh.2012.02.013. Epub 2012 Feb 16.
PubMed 22366157Mathes CM, Letourneau C, Blonde GD, le Roux CW, Spector AC. Roux-en-Y gastric bypass in rats progressively decreases the proportion of fat calories selected from a palatable cafeteria diet. Am J Physiol Regul Integr Comp Physiol. 2016 May 15;310(10):R952-9. doi: 10.1152/ajpregu.00444.2015. Epub 2016 Feb 10.
PubMed 26864811Livingstone MBE, Redpath T, Naseer F, Boyd A, Martin M, Finlayson G, Miras AD, Bodnar Z, Kerrigan D, Pournaras DJ, le Roux CW, Spector AC, Price RK. Food Intake Following Gastric Bypass Surgery: Patients Eat Less but Do Not Eat Differently. J Nutr. 2022 Nov;152(11):2319-2332. doi: 10.1093/jn/nxac164. Epub 2022 Jul 23.
PubMed 36774099Gero D, File B, Justiz J, Steinert RE, Frick L, Spector AC, Bueter M. Drinking microstructure in humans: A proof of concept study of a novel drinkometer in healthy adults. Appetite. 2019 Feb 1;133:47-60. doi: 10.1016/j.appet.2018.08.012. Epub 2018 Sep 1.
PubMed 30179650Gero D, File B, Alceste D, Frick LD, Serra M, Ismaeil AE, Steinert RE, Spector AC, Bueter M. Microstructural changes in human ingestive behavior after Roux-en-Y gastric bypass during liquid meals. JCI Insight. 2021 Aug 9;6(15):e136842. doi: 10.1172/jci.insight.136842.
PubMed 34369388Gero D, Bueter M. Post-bariatric changes in ingestive behavior: Shift in macronutrient preferences in rats and dynamic adaptation of the within-meal microstructure in humans. Physiol Behav. 2023 May 1;263:114113. doi: 10.1016/j.physbeh.2023.114113. Epub 2023 Feb 8.
PubMed 36764423Evero N, Hackett LC, Clark RD, Phelan S, Hagobian TA. Aerobic exercise reduces neuronal responses in food reward brain regions. J Appl Physiol (1985). 2012 May;112(9):1612-9. doi: 10.1152/japplphysiol.01365.2011. Epub 2012 Mar 1.
PubMed 22383502
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating in Humans the Impact of Training Status on Dietary Consumption With Direct Measurement of Ingestive Behaviour
- ClinicalTrials.gov ID
- NCT07082582
- Acronym / sponsor ID
- HITS / 2024-00926
- Conditions
- Food Intake Regulation, Training Status
- Keywords
- Ingestive behavior, Gut Hormones, Drinkometer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Michele SerraUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the research project is to investigate the influence of training status on ingestive behavior and postprandial physiological responses in the human body. The investigators aim to understand how regular training influences the choice and amount of food consumed, as well as the associated physiological processes, including changes in the spectrum of gut hormones. The investigators are particularly interested in how these factors differ between individuals who train regularly compared to those who do not follow a structured training program.
The research project aims to translate findings from previous animal experiments to humans and to examine whether and how training affects food handling and physiological responses, similar to observations made in rodents. This information could significantly contribute to improving recommendations for diet and physical activity in the population.
Detailed description
The goal of the proposed research is to identify the differences in ingestive behavior that might be caused by the training status in humans after long-term structured exercise. For this, the investigators plan to investigate and cross-sectionally compare microstructural parameters of ingestive behavior between individuals with trained and untrained status when offered three different meals (high-carbohydrate, high-fat, high-sucrose lactose-free milk) separately or concurrently.
Furthermore, the investigators propose to explore a possible correlation between microstructural parameters of ingestive behavior and postprandial levels of several gut hormones, and to investigate the differences in the composition and activity of the gut microbiome between the two groups, especially in relation to the observed ingestive behavior. Finally, the investigators will investigate the relationship between ingestive behavior and body composition separately for the two groups.
The microstructure of ingestive behavior of both male and female individuals in relation to training status has never been investigated in a direct measurement approach before and the investigators of this project are the only one that currently have both the technical requirements as well as the necessary experience to carry out such studies.
The previous research project "Direct measurement of changes in food selection and intake behavior after RYGB surgery" (NCT04933305, NCT03747445) was successful. Although recruitment and retention of study participants was significantly hindered by the COVID-19 pandemic after March 2020, the investigators were able to publish four peer-reviewed scientific articles out of the proposed studies so far. Four additional manuscripts are currently in preparation.
The present research project builds logically on previous work in the field of bariatric surgery and builds a new collaborations with Prof. J. Nicholas Betley and Dr. Lavinia Boccia (University of Pennsylvania, USA). This collaboration will surely lead to relevant findings which will be published in at least two peer-reviewed publications.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with trained Status | – | –Trained status: continuous participation in a structured training program for at least the past six months, in addition to meeting the minimum requirement of physical activity of 150 min of moderate physical activity or 75 min of vigorous physical activity per week. |
| Participants with untrained Status | – | –Untrained status: No participation in any structured training program for the last six months, in addition to not performing physical activity above 150 min of moderate physical activity or 75 min of vigorous physical activity per week. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants in the trained group are recruited from a rowing club affiliated with the University of Zürich (UZH) and Federal Technical institute of Zürich (ETH). Participants in the untrained group are recruited from students and employees of UZH and ETH.
Key inclusion criteria (7 listed)
- Training status classified as "trained" or "untrained",
- Chronological age ≥ 18 and ≤ 35,
- Body Mass Index ≥ 18.5 and ≤ 26,
- Current enrolment in a university,
- Language: English or German, with a sufficient English proficiency to fill out the food questionnaire,
Key exclusion criteria (12 listed)
- History of previous metabolic and bariatric surgery,
- Current use of medications for medical treatment (excluding contraceptive measures),
- Current use of over-the-counter medications for weight loss or appetite control,
- Current medical diagnosis of metabolic disorders (such as type
- 1 or 2 diabetes mellitus),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy Intake from Liquid Meal Consumption
Time frame: From enrolment to the end of the study participation through four study visits within three months.
Total energy intake (in kilocalories) from consumption of high-carbohydrate, high-sucrose, and high-fat lactose-free milk during each visit. Intake is measured using a drinkometer device that quantifies the exact volume consumed, which is then converted into kilocalories based on the known energy density of each meal type. The unit of measure is kilocalories (kcal).
Macrostructure of Ingestive Behavior (Rate of Energy Intake)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months
The rate of energy intake is calculated for each participant during the ingestion of each of the three test stimuli, based on standardized measurements from the drinkometer system. This measure reflects the average caloric intake per second over the course of the test stimulus consumption. Energy intake is determined by the volume of liquid consumed, multiplied by the known caloric density of the test stimulus, and divided by the duration of the ingestion period. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, in which a single test stimulus is administered at each visit. It is not measured during the fourth study visit, where all three test stimuli are presented simultaneously.
Macrostructure of Ingestive Behavior (Meal Duration)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Meal duration is defined as the total time taken by each participant to consume each of the three test stimuli, measured using the standardized drinkometer system. For each stimulus, the duration is recorded from the initiation of ingestion (first measurable suck) to the completion of consumption (last measurable suck). The unit of measure is seconds (s). This outcome is assessed during the first three study visits, each involving the administration of a single test stimulus. Meal duration is not measured during the fourth study visit, where all three test stimuli are offered to participants simultaneously.
Macrostructure of Ingestive Behavior (Number of Sucks)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
The primary outcome is the number of sucks performed by each participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "suck" is defined as a discrete negative pressure event generated by the participant to draw in liquid, as detected by the drinkometer's calibrated weight sensors. For each stimulus, the total number of sucks is recorded as a simple count, with the unit of measure being "number (n)." The outcome is assessed during the first three study visits, each of which features a single test stimulus administered in a standardized fashion. This outcome is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously to the participant.
Microstructure of Ingestive Behavior (Suck Energy Intake)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Suck energy intake is defined as the total amount of energy (in kilocalories) consumed by the participant during each individual suck, measured for each of the three test stimuli using a standardized drinkometer system. For each test stimulus, the total caloric intake is calculated by multiplying the volume of liquid ingested by its caloric density and summing the values across all measured sucks. The unit of measure is kilocalories (kcal). This outcome is assessed during the first three study visits, where each visit involves a single test stimulus. Suck energy intake is not measured during the fourth study visit, in which all three test stimuli are presented to the participant simultaneously.
Microstructure of Ingestive Behavior (Suck Duration)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Suck duration is defined as the time span of each individual suck performed by the participant during the ingestion of each of the three test stimuli, as measured by a standardized drinkometer system. For each test stimulus, the duration of every suck is recorded from the initiation to the completion of the negative pressure event. The unit of measure is seconds (s). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Suck duration is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Microstructure of Ingestive Behavior (Suck Rate)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Suck rate is defined as the average energy intake of liquid ingested per second during each individual suck, measured for each of the three test stimuli using a standardized drinkometer system. For each test stimulus, the energy intake consumed during each suck is divided by the corresponding suck duration to determine the rate of ingestion for that event. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Suck rate is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Microstructure of Ingestive Behavior (Suck Maximal Rate)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Suck maximal rate is defined as the highest instantaneous rate of liquid ingestion (in kilocalories per second) achieved during any single suck by the participant for each of the three test stimuli, as measured using a standardized drinkometer system. For each test stimulus, the maximal rate is determined by identifying the suck with the greatest energy intake per unit time among all measured sucks during the ingestion period. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, with each visit involving a single test stimulus. Suck maximal rate is not measured during the fourth study visit, where all three test stimuli are presented simultaneously.
Microstructure of Ingestive Behavior (Burst Number)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Burst number is defined as the total count of distinct bursts performed by the participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of successive sucks separated by brief pauses, typically reflecting a rhythmic drinking pattern. For each test stimulus, the number of such bursts is recorded as an integer value. The unit of measure is "number of bursts" (n). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Burst number is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Microstructure of Ingestive Behavior (Burst Duration)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Burst duration is defined as the total elapsed time of each individual burst performed by the participant during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the duration is measured from the onset of the first suck to the end of the last suck within the burst. The unit of measure is seconds (s). This outcome is assessed during the first three study visits, with each visit involving a single test stimulus. Burst duration is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Microstructure of Ingestive Behavior (Burst Energy Intake)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Burst energy intake is defined as the total amount of energy intake (in kilocalories) consumed during each individual burst by the participant, measured for each of the three test stimuli using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the energy intake is calculated by multiplying the volume of liquid ingested within the burst by the energy density of the test stimulus. The unit of measure is kilocalories (kcal). This outcome is assessed during the first three study visits, each involving a single test stimulus. Burst size is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.
Microstructure of Ingestive Behavior (Burst Rate)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Burst rate is defined as the average rate of energy intake during each individual burst performed by the participant for each of the three test stimuli, as measured using a standardized drinkometer system. For each burst, the total energy intake (in kilocalories) is divided by the duration of the burst (in seconds) to determine the average rate of energy intake for that burst. The unit of measure is kilocalories per second (kcal/s). This outcome is assessed during the first three study visits, each involving a single test stimulus. Burst rate is not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.
Microstructure of Ingestive Behavior (Number of Sucks per Burst)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Number of sucks per burst is defined as the average count of individual sucks occurring within each burst during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. For each burst, the total number of sucks is recorded, and the outcome is typically reported as the mean number of sucks per burst. The unit of measure is "number of sucks per burst" (n). This outcome is assessed during the first three study visits, where a single test stimulus is administered at each visit. Number of sucks per burst is not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
Microstructure of Ingestive Behavior (Inter-Burst Intervals)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Inter-burst interval is defined as the elapsed time between the end of one burst and the onset of the subsequent burst during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "burst" is operationally defined as a sequence of consecutive sucks separated by brief pauses. The inter-burst interval quantifies the temporal spacing between bursts and is recorded in seconds (s). This outcome is assessed during the first three study visits, each involving a single test stimulus. Inter-burst intervals are not measured during the fourth study visit, in which all three test stimuli are offered simultaneously.
Microstructure of Ingestive Behavior (Inter-Sucks Intervals)
Time frame: From enrolment to the end of the study participation through three of four study visits within three months.
Inter-suck interval is defined as the elapsed time between the end of one suck and the initiation of the subsequent suck during the ingestion of each of the three test stimuli, as measured using a standardized drinkometer system. A "suck" is operationally defined as a discrete negative pressure event corresponding to the drawing in of liquid. The inter-suck interval quantifies the temporal spacing between individual sucks within a burst or throughout the test stimulus consumption, and is recorded in seconds (s). This outcome is assessed during the first three study visits, each involving a single test stimulus. Inter-suck intervals are not measured during the fourth study visit, in which all three test stimuli are presented simultaneously.
17 secondary outcomes
Plasma GLP-1 Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma GIP Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Amylin Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma PYY Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Ghrelin Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Leptin Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Insulin Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma CCK Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Glucagon Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Plasma Serotonin Concentration
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Hunger
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Fullness
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Desire To Eat
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Nausea
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Abdominal Discomfort
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly at the end of the drinkometer test, and 30 minutes after the end of the drinkometer test.
Gut Microbiome Composition (Alpha and Beta Diversity)
Time frame: Up to 14 days after study enrollment (microbiome diversity measured from two stool samples per participant: one in the morning, after afternoon; timing based on participant's natural bowel movement occurrence)
Gut Microbiome Functional Activity (Metabolite Analysis)
Time frame: Up to 14 days after study enrollment (microbiome diversity measured from two stool samples per participant: one in the morning, after afternoon; timing based on participant's natural bowel movement occurrence)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 31125091Zouhal H, Sellami M, Saeidi A, Slimani M, Abbassi-Daloii A, Khodamoradi A, El Hage R, Hackney AC, Ben Abderrahman A. Effect of physical exercise and training on gastrointestinal hormones in populations with different weight statuses. Nutr Rev. 2019 Jul 1;77(7):455-477. doi: 10.1093/nutrit/nuz005.
- Background: PubMed 34203776Strasser B, Wolters M, Weyh C, Kruger K, Ticinesi A. The Effects of Lifestyle and Diet on Gut Microbiota Composition, Inflammation and Muscle Performance in Our Aging Society. Nutrients. 2021 Jun 15;13(6):2045. doi: 10.3390/nu13062045.
- Background: PubMed 30421858Sondergaard Nielsen M, Rasmussen S, Just Christensen B, Ritz C, le Roux CW, Berg Schmidt J, Sjodin A. Bariatric Surgery Does Not Affect Food Preferences, but Individual Changes in Food Preferences May Predict Weight Loss. Obesity (Silver Spring). 2018 Dec;26(12):1879-1887. doi: 10.1002/oby.22272. Epub 2018 Nov 13.
- Background: PubMed 35620756Serra M, File B, Alceste D, Raguz I, Gero D, Thalheimer A, Widmer J, Ismaeil A, Steinert RE, Spector AC, Bueter M. Burst-pause criterion derivation for drinkometer measurements of ingestive behavior. MethodsX. 2022 May 11;9:101726. doi: 10.1016/j.mex.2022.101726. eCollection 2022.
- Background: PubMed 32624568Quiroga R, Nistal E, Estebanez B, Porras D, Juarez-Fernandez M, Martinez-Florez S, Garcia-Mediavilla MV, de Paz JA, Gonzalez-Gallego J, Sanchez-Campos S, Cuevas MJ. Exercise training modulates the gut microbiota profile and impairs inflammatory signaling pathways in obese children. Exp Mol Med. 2020 Jul;52(7):1048-1061. doi: 10.1038/s12276-020-0459-0. Epub 2020 Jul 6.
- Background: PubMed 28411313Nielsen MS, Christensen BJ, Ritz C, Rasmussen S, Hansen TT, Bredie WLP, le Roux CW, Sjodin A, Schmidt JB. Roux-En-Y Gastric Bypass and Sleeve Gastrectomy Does Not Affect Food Preferences When Assessed by an Ad libitum Buffet Meal. Obes Surg. 2017 Oct;27(10):2599-2605. doi: 10.1007/s11695-017-2678-6.
- Background: PubMed 25791204Moody L, Liang J, Choi PP, Moran TH, Liang NC. Wheel running decreases palatable diet preference in Sprague-Dawley rats. Physiol Behav. 2015 Oct 15;150:53-63. doi: 10.1016/j.physbeh.2015.03.019. Epub 2015 Mar 16.
- Background: PubMed 28357027Monda V, Villano I, Messina A, Valenzano A, Esposito T, Moscatelli F, Viggiano A, Cibelli G, Chieffi S, Monda M, Messina G. Exercise Modifies the Gut Microbiota with Positive Health Effects. Oxid Med Cell Longev. 2017;2017:3831972. doi: 10.1155/2017/3831972. Epub 2017 Mar 5.
- Background: PubMed 22366157Mathes CM, Spector AC. Food selection and taste changes in humans after Roux-en-Y gastric bypass surgery: a direct-measures approach. Physiol Behav. 2012 Nov 5;107(4):476-83. doi: 10.1016/j.physbeh.2012.02.013. Epub 2012 Feb 16.
- Background: PubMed 26864811Mathes CM, Letourneau C, Blonde GD, le Roux CW, Spector AC. Roux-en-Y gastric bypass in rats progressively decreases the proportion of fat calories selected from a palatable cafeteria diet. Am J Physiol Regul Integr Comp Physiol. 2016 May 15;310(10):R952-9. doi: 10.1152/ajpregu.00444.2015. Epub 2016 Feb 10.
- Background: PubMed 36774099Livingstone MBE, Redpath T, Naseer F, Boyd A, Martin M, Finlayson G, Miras AD, Bodnar Z, Kerrigan D, Pournaras DJ, le Roux CW, Spector AC, Price RK. Food Intake Following Gastric Bypass Surgery: Patients Eat Less but Do Not Eat Differently. J Nutr. 2022 Nov;152(11):2319-2332. doi: 10.1093/jn/nxac164. Epub 2022 Jul 23.
- Background: PubMed 30179650Gero D, File B, Justiz J, Steinert RE, Frick L, Spector AC, Bueter M. Drinking microstructure in humans: A proof of concept study of a novel drinkometer in healthy adults. Appetite. 2019 Feb 1;133:47-60. doi: 10.1016/j.appet.2018.08.012. Epub 2018 Sep 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Intake Regulation and Training Status, run by Michele Serra at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Intake from Liquid Meal Consumption (time frame: From enrolment to the end of the study participation through four study visits within three months.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07082582, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.