Metabolic DiseaseDIGRATNCT07457424
Direct Measurement of Microstructure of Ingestive Behaviour After Initiation of GLP-1 Receptor Agonist Treatment at Maximum Dose (DIGRAT)
An observational study of Metabolic Disease and Obesity & Overweight, run by University College Dublin at 1 site in Ireland.
Trial summary
Ingestion of food instigates the release of a battery of enteroendocrine peptide hormones that help control gut motility and digestive secretion. Peptide hormone products of the enteroendocrine L-cell and GLP-1 in particular, play multiple roles in relation to the regulation of pancreatic islet function and gastric… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Obesity & Overweight
- What is being tested?
- semaglutide 1 mg weekly injection
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteIreland
- Study dates
- 17 Feb 2022to 31 Jan 2027
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with BM>30 who are started GLP-1 for treating obesity and people with BMI>30 without using internal weight loss measures and no history of GLP-1 analog. Also, healthy people with BMI>18.5 and <24.9 are involved in the study.
Who may be able to join
- Age 18 to 75
- Treatment Group: BMI > 30 kg/m2 and clinically indicated for GLP-1 RA's treatment.
- Controls with obesity (BMI ≥ 30 kg/m2) with no history of GLP-1 RA's treatment.
- Healthy normal weight controls (BMI < 25 kg/m2) with no history of using GLP-1 RAs
- Independently mobile
- Capacity to consent to participate
Who cannot join
- Pre-treatment factors impairing the ability to consume meal such as Significant dysphagia
- Gastric outlet obstruction
- Systemic or gastrointestinal condition which may affect food intake or preference
- Pregnancy or lactation (At the beginning of each study visit, a urine pregnancy test will be performed for all female participants).
- Active and significant psychiatric illness including substance misuse
- Significant cognitive or communication issues
- Medications with documented effects on food intake or food preference
- History of significant food allergy and certain dietary restrictions (except for lactose intolerance)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Measurement of Changes in Food Selection and Intake Behaviour After Using the Maximum Dose of GLP-1 Receptor Agonists
Ingestion of food instigates the release of a battery of enteroendocrine peptide hormones that help control gut motility and digestive secretion. Peptide hormone products of the enteroendocrine L-cell and GLP-1 in particular, play multiple roles in relation to the regulation of pancreatic islet function and gastric emptying and the induction of satiety pathways in the central nervous system The mechanism of action of GLP-1 RAs on food intake reduction is mainly mediated through both peripheral and central nervous system (CNS) pathways. GLP-1 RAs directly stimulates POMC neurons and inhibits neuropeptide-Y (NPY) and Agouti-related peptide (AgRP) neurons in the arcuate nucleus resulting in a reduction in hunger and increases in fullness4.
While there were studies which indirectly measured the changes of food preference and eating behaviour in humans after using GLP-1 RAs via visual analogue scales (VAS) or Patient's Experiences Questionnaires the investigators found there is a necessity to conduct the studies to do direct measurements of the changes of food preference and eating behaviour. Direct measures of an altered food selection in humans after using GLP-1 RAs have virtually not been performed likely due to the significant methodological and conceptual challenges they pose to researchers and study design. However, direct measures represent an essential component in the attempt to understand how GLP-1 RAs alters eating and diet selection which is the main reason of conducting this study. This innovative experiment will be a critical and a novel test of the explicit experience of humans with high-sugar high-fat fluids after using GLP-1 RAs and its potential role for the understanding of possible mechanisms determining post-treatment outcome such as weight loss.
Read the detailed description
Food intake results in the feeling of fullness, but different foods with the same energy value may induce a variable amount of fullness. Many of the satiety signals come from the lower part of the small intestine where satiety hormones are released.
Obesity is associated with impaired metabolic pathways along with disordered signalling of appetite, hence individuals with obesity experience symptoms that manifest as an increase in hunger and lack of fullness. Thus, using analogues of our natural satiety/fullness hormones in individuals with obesity can suppress excessive hunger and increase fullness via slowing down gastric emptying, increasing secretion of insulin and satiety hormones and affecting on Brain-Gut axis which leads to less calorie intake and weight loss.
In this study, the investigators want to review the changes in the microstructure of ingestive behaviour of participants after using the maximum dose of an obesity management medication which is similar to our natural satiety hormone via a specific device named drinkometer allowing real-time measurement of subjects' intake rate and total volume intake of one standardised liquid meal. The drinkometer device consists of an electronic scale on which a container with the liquid meal is set at each study visit in the Clinical Research Centre of St. Vincent's University Hospital. Guidance, fixed to a casing around the balance container system, delivers a tube close to the bottom of the container. The other end of the opaque tube extends to the subject and allows the sampling of the liquid meal via a mouthpiece. The tube, mouthpiece and liquid container are biocompatible and food safe. The participants will attend five visits in total including 1) Pre-Intervention site visit, 2) 4 weeks after initiation of the treatment, 3) at 12 weeks, when maximum dose is reached, 4) 26 weeks after initiation, still at maximum dose, 5) 52 weeks after initiation, still at maximum dose.
The primary objective of the study is to use an analysis of ingestive behaviour to test the hypothesis that using a maximum dose of a GLP-1 receptor agonist medication changes the microstructure of the ingestive behaviour with specific patterns that can be used for behavioural phenotyping and therefore, treatment decision and prediction of the clinical outcomes.
- Conditions
- Metabolic Disease, Obesity & Overweight
- Being tested
- semaglutide 1 mg weekly injection
- Keywords
- eating behaviour, appetite, gut hormones, microstructure of the ingestive behaviour, Behavioural phenotyping, GLP-1 receptor agonist, Semaglutide
- Medical subject headings
- Metabolic Diseases, Obesity, Overweight, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutide 1 mg weekly injectionDrug
Also called Ozempic
Initiation of semaglutide treatment with weekly injection. The patient starts at 0.25 mg for 4 weeks and then the dose escalates at 0.5 mg. The maximum dose of 1 mg is reached at week 12. The patients decided to undergo the treatment before they were recruited in the study.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Subjects with obesity (BMI>30) who are starting Glucagon-like peptide analogs medicine for obesity treatment Receives: Drug: semaglutide 1 mg weekly injection | |
| Control with normal weight | Healthy subjects with normal BMI value | |
| Control with obesity | Study population with obesity not undergoing any treatment |
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: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Macrostructure of Ingestive Behaviour (Rate of Energy Intake)
The rate of energy intake is calculated for each participant during the ingestion of each of the one stimuli, based on standardised 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 five study visits, in which a one test stimulus is administered at each visit.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Macrostructure of Ingestive Behaviour (Meal Duration)
Meal duration is defined as the total time taken by each participant to consume the liquid meal, measured using the standardised drinkometer system. 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 five study visits. The test stimuli are offered to participants simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Macrostructure of Ingestive Behaviour (Number of Sucks)
The primary outcome is the number of sucks performed by each participant during the ingestion of the liquid meal as measured using a standardised 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 the stimulus, the total number of sucks is recorded as a simple count, with the unit of measure being "number (n)." The outcome is assessed at each of the five study visits, each of which features a single test stimulus administered in a standardised fashion.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (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 test stimuli using a standardised 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 five study visits, test stimuli are presented to the participant simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (Suck Duration)
Suck duration is defined as the time span of each individual suck performed by the participant during the ingestion the liquid meal test stimuli, as measured by a standardised 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 five study visits, where the stimulus of the liquid meal is administered at each visit. The test stimuli are presented simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (Suck Rate)
Suck rate is defined as the average energy intake of liquid ingested per second during each suck, measured for the test stimuli using a standardised drinkometer system. 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 five study visits, where the single test stimulus is administered at each visit. The test stimuli are presented simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (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 the test stimuli, as measured using a standardised drinkometer system. For the 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 five study visits where the stimuli are presented simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (Burst Number)
Burst number is defined as the total count of distinct bursts performed by the participant during the ingestion of the stimuli, as measured using a standardised drinkometer system. A "burst" is operationally defined as a sequence of successive sucks separated by brief pauses, typically reflecting a rhythmic drinking pattern. For the 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 five study visits, where the test stimuli is presented simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (Burst Duration)
Burst duration is defined as the total elapsed time of each individual burst performed by the participant during the ingestion of the test stimuli, as measured using a standardised 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 five study visits, where the test stimulus is presented simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (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 the test stimuli using a standardised 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 five study visits, where the test stimuli is offered simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (Burst Rate)
Burst rate is defined as the average rate of energy intake during each individual burst performed by the participant for the test stimuli, as measured using a standardised 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 five study visits, where the test stimuli are offered simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behavior (Number of Sucks per Burst)
The number of sucks per burst is defined as the average count of individual sucks occurring within each burst during the ingestion of the test stimuli, as measured using a standardised 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 five study visits, where the test stimuli are presented simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (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 the test stimuli, as measured using a standardised 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 five study visits, the stimulus is offered simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Microstructure of Ingestive Behaviour (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 test stimulus, as measured using a standardised 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 five study visits, where the test stimulus is presented simultaneously.
Measured: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Secondary outcomes (14)
Plasma GLP-1 Concentration
Change in GLP-1 concentration (pmol/L) 30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: GLP-1 concentrations are measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma GIP Concentration
Change in GIP concentration (pmol/L) post-liquid meal drink (30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: GIP concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Amylin Concentration
Change in amylin concentration (pmol/L) post-liquid meal drink ( 30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: Amylin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma PYY Concentration
Change in PYY concentration (pmol/L) post-liquid meal drink (30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: PYY concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Ghrelin Concentration
Change in ghrelin concentration (pmol/L) post-liquid meal drink (30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: Ghrelin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Leptin Concentration
Change in leptin concentration (pmol/L) post-liquid meal drink (30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: Leptin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Insulin Concentration
Change in insulin concentration (pmol/L) post-liquid meal drink (30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: Insulin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma CCK Concentration
CCK concentration (pmol/L) post-liquid meal drink (30 minutes after ingestion), across the three meal types. Unit of measure is picomoles per liter (pmol/L).
Measured: CCK concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Glucagon Concentration
Change in glucagon concentration (pmol/L) post-liquid meal drink (30 minutes after ingestion). Unit of measure is picomoles per liter (pmol/L).
Measured: Glucagon concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52
Subjective Appetite Sensation: Hunger
Self-reported hunger is assessed using a 100 mm Visual Analogue Scale (VAS) ranging from 0 mm, 'not hungry at all', to 100 mm, 'extremely hungry'.
Higher scores indicate greater hunger. Unit of measure: millimeters (mm).
Measured: Measured at 3 time points per visit: before the drinkometer test, directly after the drinkometer test, and 30 minutes after the end of the drinkometer test.
Subjective Appetite Sensation: Fullness
Self-reported fullness is assessed using a 100 mm Visual Analogue Scale (VAS) ranging from 0 mm, 'not full at all', to 100 mm, 'extremely full'.
Higher scores indicate greater fullness. 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 is assessed using a 100 mm Visual Analogue Scale (VAS) ranging from 0 mm, 'no desire to eat at all', to 100 mm, 'extreme desire to eat'.
Higher scores indicate the greater desire to eat. 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 is assessed using a 100 mm Visual Analogue Scale (VAS) ranging from 0 mm, 'not nauseous at all', to 100 mm, 'extremely nauseous'.
Higher scores indicate greater nausea. 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 is assessed using a 100 mm Visual Analogue Scale (VAS) ranging from 0 mm, 'no abdominal discomfort at all', to 100 mm, 'extreme abdominal discomfort'.
Higher scores indicate greater abdominal discomfort. 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start17 Feb 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies 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
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457424
- Sponsor's protocol ID
- RS21-065
- Acronym
- DIGRAT
- Status last verified
- May 2026
- First submitted
- 5 Mar 2024
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serra 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 35620756Zoh RS, Esteves BH, Yu X, Fairchild AJ, Vazquez AI, Chapple AG, Brown AW, George B, Gordon D, Landsittel D, Gadbury GL, Pavela G, de Los Campos G, Mestre LM, Allison DB. Design, analysis, and interpretation of treatment response heterogeneity in personalized nutrition and obesity treatment research. Obes Rev. 2023 Dec;24(12):e13635. doi: 10.1111/obr.13635. Epub 2023 Sep 4.
PubMed 37667550Chou T, Hoover AW, Goldstein SP, Greco-Henderson D, Martin CK, Raynor HA, Muth ER, Thomas JG. An explanation for the accuracy of sensor-based measures of energy intake: Amount of food consumed matters more than dietary composition. Appetite. 2024 Mar 1;194:107176. doi: 10.1016/j.appet.2023.107176. Epub 2023 Dec 27.
PubMed 38154576Gero 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 34369388Alceste D, Serra M, Raguz I, Gero D, Thalheimer A, Widmer J, File B, Ismaeil A, Steinert RE, Spector AC, Bueter M. Association between microstructure of ingestive behavior and body weight loss in patients one year after Roux-en-Y gastric bypass. Physiol Behav. 2022 May 1;248:113728. doi: 10.1016/j.physbeh.2022.113728. Epub 2022 Feb 5.
PubMed 35134394Kissileff HR. The Universal Eating Monitor (UEM): objective assessment of food intake behavior in the laboratory setting. Int J Obes (Lond). 2022 Jun;46(6):1114-1121. doi: 10.1038/s41366-022-01089-0. Epub 2022 Mar 1.
PubMed 35233038Camacho-Barcia L, Giel KE, Jimenez-Murcia S, Alvarez Pitti J, Micali N, Lucas I, Miranda-Olivos R, Munguia L, Tena-Sempere M, Zipfel S, Fernandez-Aranda F. Eating disorders and obesity: bridging clinical, neurobiological, and therapeutic perspectives. Trends Mol Med. 2024 Apr;30(4):361-379. doi: 10.1016/j.molmed.2024.02.007. Epub 2024 Mar 14.
PubMed 38485648Berthoud HR, Seeley RJ, Roberts SB. Physiology of Energy Intake in the Weight-Reduced State. Obesity (Silver Spring). 2021 Apr;29 Suppl 1:S25-S30. doi: 10.1002/oby.23080.
PubMed 33759396Pitts T, Iceman KE. Deglutition and the Regulation of the Swallow Motor Pattern. Physiology (Bethesda). 2023 Jan 1;38(1):0. doi: 10.1152/physiol.00005.2021. Epub 2022 Aug 23.
PubMed 35998250Johansen VBI, Petersen J, Lund J, Mathiesen CV, Fenselau H, Clemmensen C. Brain control of energy homeostasis: Implications for anti-obesity pharmacotherapy. Cell. 2025 Aug 7;188(16):4178-4212. doi: 10.1016/j.cell.2025.06.010.
PubMed 40780185Watts AG, Kanoski SE, Sanchez-Watts G, Langhans W. The physiological control of eating: signals, neurons, and networks. Physiol Rev. 2022 Apr 1;102(2):689-813. doi: 10.1152/physrev.00028.2020. Epub 2021 Sep 6.
PubMed 34486393
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
- Direct Measurement of Changes in Food Selection and Intake Behaviour After Using the Maximum Dose of GLP-1 Receptor Agonists
- ClinicalTrials.gov ID
- NCT07457424
- Acronym / sponsor ID
- DIGRAT / RS21-065
- Conditions
- Metabolic Disease, Obesity & Overweight
- Keywords
- eating behaviour, appetite, gut hormones, microstructure of the ingestive behaviour, Behavioural phenotyping, GLP-1 receptor agonist, Semaglutide
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Mar 2026 (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.
Ingestion of food instigates the release of a battery of enteroendocrine peptide hormones that help control gut motility and digestive secretion. Peptide hormone products of the enteroendocrine L-cell and GLP-1 in particular, play multiple roles in relation to the regulation of pancreatic islet function and gastric emptying and the induction of satiety pathways in the central nervous system The mechanism of action of GLP-1 RAs on food intake reduction is mainly mediated through both peripheral and central nervous system (CNS) pathways. GLP-1 RAs directly stimulates POMC neurons and inhibits neuropeptide-Y (NPY) and Agouti-related peptide (AgRP) neurons in the arcuate nucleus resulting in a reduction in hunger and increases in fullness4.
While there were studies which indirectly measured the changes of food preference and eating behaviour in humans after using GLP-1 RAs via visual analogue scales (VAS) or Patient's Experiences Questionnaires the investigators found there is a necessity to conduct the studies to do direct measurements of the changes of food preference and eating behaviour. Direct measures of an altered food selection in humans after using GLP-1 RAs have virtually not been performed likely due to the significant methodological and conceptual challenges they pose to researchers and study design. However, direct measures represent an essential component in the attempt to understand how GLP-1 RAs alters eating and diet selection which is the main reason of conducting this study. This innovative experiment will be a critical and a novel test of the explicit experience of humans with high-sugar high-fat fluids after using GLP-1 RAs and its potential role for the understanding of possible mechanisms determining post-treatment outcome such as weight loss.
Detailed description
Food intake results in the feeling of fullness, but different foods with the same energy value may induce a variable amount of fullness. Many of the satiety signals come from the lower part of the small intestine where satiety hormones are released.
Obesity is associated with impaired metabolic pathways along with disordered signalling of appetite, hence individuals with obesity experience symptoms that manifest as an increase in hunger and lack of fullness. Thus, using analogues of our natural satiety/fullness hormones in individuals with obesity can suppress excessive hunger and increase fullness via slowing down gastric emptying, increasing secretion of insulin and satiety hormones and affecting on Brain-Gut axis which leads to less calorie intake and weight loss.
In this study, the investigators want to review the changes in the microstructure of ingestive behaviour of participants after using the maximum dose of an obesity management medication which is similar to our natural satiety hormone via a specific device named drinkometer allowing real-time measurement of subjects' intake rate and total volume intake of one standardised liquid meal. The drinkometer device consists of an electronic scale on which a container with the liquid meal is set at each study visit in the Clinical Research Centre of St. Vincent's University Hospital. Guidance, fixed to a casing around the balance container system, delivers a tube close to the bottom of the container. The other end of the opaque tube extends to the subject and allows the sampling of the liquid meal via a mouthpiece. The tube, mouthpiece and liquid container are biocompatible and food safe. The participants will attend five visits in total including 1) Pre-Intervention site visit, 2) 4 weeks after initiation of the treatment, 3) at 12 weeks, when maximum dose is reached, 4) 26 weeks after initiation, still at maximum dose, 5) 52 weeks after initiation, still at maximum dose.
The primary objective of the study is to use an analysis of ingestive behaviour to test the hypothesis that using a maximum dose of a GLP-1 receptor agonist medication changes the microstructure of the ingestive behaviour with specific patterns that can be used for behavioural phenotyping and therefore, treatment decision and prediction of the clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: semaglutide 1 mg weekly injectionSubjects with obesity (BMI>30) who are starting Glucagon-like peptide analogs medicine for obesity treatment |
| Control with normal weight | – | –Healthy subjects with normal BMI value |
| Control with obesity | – | –Study population with obesity not undergoing any treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with BM>30 who are started GLP-1 for treating obesity and people with BMI>30 without using internal weight loss measures and no history of GLP-1 analog. Also, healthy people with BMI>18.5 and <24.9 are involved in the study.
Key inclusion criteria (6 listed)
- Age 18 to 75
- Independently mobile
- Capacity to consent to participate
Key exclusion criteria (8 listed)
- Pre-treatment factors impairing the ability to consume meal such as Significant dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutide 1 mg weekly injectionAlso: OzempicInitiation of semaglutide treatment with weekly injection. The patient starts at 0.25 mg for 4 weeks and then the dose escalates at 0.5 mg. The maximum dose of 1 mg is reached at week 12. The patients decided to undergo the treatment before they were recruited in the study. | Drug | Treatment group |
Primary outcome
Energy Intake from Liquid Meal Consumption
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
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 Behaviour (Rate of Energy Intake)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
The rate of energy intake is calculated for each participant during the ingestion of each of the one stimuli, based on standardised 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 five study visits, in which a one test stimulus is administered at each visit.
Macrostructure of Ingestive Behaviour (Meal Duration)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Meal duration is defined as the total time taken by each participant to consume the liquid meal, measured using the standardised drinkometer system. 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 five study visits. The test stimuli are offered to participants simultaneously.
Macrostructure of Ingestive Behaviour (Number of Sucks)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
The primary outcome is the number of sucks performed by each participant during the ingestion of the liquid meal as measured using a standardised 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 the stimulus, the total number of sucks is recorded as a simple count, with the unit of measure being "number (n)." The outcome is assessed at each of the five study visits, each of which features a single test stimulus administered in a standardised fashion.
Microstructure of Ingestive Behaviour (Suck Energy Intake)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Suck energy intake is defined as the total amount of energy (in kilocalories) consumed by the participant during each individual suck, measured for test stimuli using a standardised 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 five study visits, test stimuli are presented to the participant simultaneously.
Microstructure of Ingestive Behaviour (Suck Duration)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Suck duration is defined as the time span of each individual suck performed by the participant during the ingestion the liquid meal test stimuli, as measured by a standardised 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 five study visits, where the stimulus of the liquid meal is administered at each visit. The test stimuli are presented simultaneously.
Microstructure of Ingestive Behaviour (Suck Rate)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Suck rate is defined as the average energy intake of liquid ingested per second during each suck, measured for the test stimuli using a standardised drinkometer system. 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 five study visits, where the single test stimulus is administered at each visit. The test stimuli are presented simultaneously.
Microstructure of Ingestive Behaviour (Suck Maximal Rate)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
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 the test stimuli, as measured using a standardised drinkometer system. For the 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 five study visits where the stimuli are presented simultaneously.
Microstructure of Ingestive Behaviour (Burst Number)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Burst number is defined as the total count of distinct bursts performed by the participant during the ingestion of the stimuli, as measured using a standardised drinkometer system. A "burst" is operationally defined as a sequence of successive sucks separated by brief pauses, typically reflecting a rhythmic drinking pattern. For the 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 five study visits, where the test stimuli is presented simultaneously.
Microstructure of Ingestive Behaviour (Burst Duration)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Burst duration is defined as the total elapsed time of each individual burst performed by the participant during the ingestion of the test stimuli, as measured using a standardised 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 five study visits, where the test stimulus is presented simultaneously.
Microstructure of Ingestive Behaviour (Burst Energy Intake)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Burst energy intake is defined as the total amount of energy intake (in kilocalories) consumed during each individual burst by the participant, measured for the test stimuli using a standardised 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 five study visits, where the test stimuli is offered simultaneously.
Microstructure of Ingestive Behaviour (Burst Rate)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
Burst rate is defined as the average rate of energy intake during each individual burst performed by the participant for the test stimuli, as measured using a standardised 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 five study visits, where the test stimuli are offered simultaneously.
Microstructure of Ingestive Behavior (Number of Sucks per Burst)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
The number of sucks per burst is defined as the average count of individual sucks occurring within each burst during the ingestion of the test stimuli, as measured using a standardised 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 five study visits, where the test stimuli are presented simultaneously.
Microstructure of Ingestive Behaviour (Inter-Burst Intervals)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
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 the test stimuli, as measured using a standardised 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 five study visits, the stimulus is offered simultaneously.
Microstructure of Ingestive Behaviour (Inter-Sucks Intervals)
Time frame: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks
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 test stimulus, as measured using a standardised 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 five study visits, where the test stimulus is presented simultaneously.
14 secondary outcomes
Plasma GLP-1 Concentration
Time frame: GLP-1 concentrations are measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma GIP Concentration
Time frame: GIP concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Amylin Concentration
Time frame: Amylin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma PYY Concentration
Time frame: PYY concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Ghrelin Concentration
Time frame: Ghrelin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Leptin Concentration
Time frame: Leptin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Insulin Concentration
Time frame: Insulin concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma CCK Concentration
Time frame: CCK concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52)
Plasma Glucagon Concentration
Time frame: Glucagon concentrations were measured 30 minutes after ingestion of the liquid meal at each study visit (baseline and weeks 4, 12, 24, and 52
Subjective Appetite Sensation: Hunger
Time frame: Measured at 3 time points per visit: before the drinkometer test, directly after 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.
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 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 37667550Zoh RS, Esteves BH, Yu X, Fairchild AJ, Vazquez AI, Chapple AG, Brown AW, George B, Gordon D, Landsittel D, Gadbury GL, Pavela G, de Los Campos G, Mestre LM, Allison DB. Design, analysis, and interpretation of treatment response heterogeneity in personalized nutrition and obesity treatment research. Obes Rev. 2023 Dec;24(12):e13635. doi: 10.1111/obr.13635. Epub 2023 Sep 4.
- Background: PubMed 38154576Chou T, Hoover AW, Goldstein SP, Greco-Henderson D, Martin CK, Raynor HA, Muth ER, Thomas JG. An explanation for the accuracy of sensor-based measures of energy intake: Amount of food consumed matters more than dietary composition. Appetite. 2024 Mar 1;194:107176. doi: 10.1016/j.appet.2023.107176. Epub 2023 Dec 27.
- Background: PubMed 34369388Gero 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.
- Background: PubMed 35134394Alceste D, Serra M, Raguz I, Gero D, Thalheimer A, Widmer J, File B, Ismaeil A, Steinert RE, Spector AC, Bueter M. Association between microstructure of ingestive behavior and body weight loss in patients one year after Roux-en-Y gastric bypass. Physiol Behav. 2022 May 1;248:113728. doi: 10.1016/j.physbeh.2022.113728. Epub 2022 Feb 5.
- Background: PubMed 35233038Kissileff HR. The Universal Eating Monitor (UEM): objective assessment of food intake behavior in the laboratory setting. Int J Obes (Lond). 2022 Jun;46(6):1114-1121. doi: 10.1038/s41366-022-01089-0. Epub 2022 Mar 1.
- Background: PubMed 38485648Camacho-Barcia L, Giel KE, Jimenez-Murcia S, Alvarez Pitti J, Micali N, Lucas I, Miranda-Olivos R, Munguia L, Tena-Sempere M, Zipfel S, Fernandez-Aranda F. Eating disorders and obesity: bridging clinical, neurobiological, and therapeutic perspectives. Trends Mol Med. 2024 Apr;30(4):361-379. doi: 10.1016/j.molmed.2024.02.007. Epub 2024 Mar 14.
- Background: PubMed 33759396Berthoud HR, Seeley RJ, Roberts SB. Physiology of Energy Intake in the Weight-Reduced State. Obesity (Silver Spring). 2021 Apr;29 Suppl 1:S25-S30. doi: 10.1002/oby.23080.
- Background: PubMed 35998250Pitts T, Iceman KE. Deglutition and the Regulation of the Swallow Motor Pattern. Physiology (Bethesda). 2023 Jan 1;38(1):0. doi: 10.1152/physiol.00005.2021. Epub 2022 Aug 23.
- Background: PubMed 40780185Johansen VBI, Petersen J, Lund J, Mathiesen CV, Fenselau H, Clemmensen C. Brain control of energy homeostasis: Implications for anti-obesity pharmacotherapy. Cell. 2025 Aug 7;188(16):4178-4212. doi: 10.1016/j.cell.2025.06.010.
- Background: PubMed 34486393Watts AG, Kanoski SE, Sanchez-Watts G, Langhans W. The physiological control of eating: signals, neurons, and networks. Physiol Rev. 2022 Apr 1;102(2):689-813. doi: 10.1152/physrev.00028.2020. Epub 2021 Sep 6.
- 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 Metabolic Disease and Obesity & Overweight, run by University College Dublin at 1 site in Ireland.
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 6 inclusion and 8 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 Ireland. 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: At baseline, 4 weeks, 12 weeks, 24 weeks, 52 weeks). 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 NCT07457424, which also lists 11 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.