MealNCT03747445
Microstructural Analysis of Ingestive Behavior After Roux-en-Y Gastric Bypass - Pilot
An observational study of Meal and Obesity, Morbid, run by Marco Bueter at 1 site in Switzerland.
Trial summary
The ability to assess ingestion in fine detail over the time course of a liquid meal allows for comparison of early and late meal features of drinking and may help dissociate manipulations (surgical, neural, pharmacological, etc.) that affect orosensory properties from those that are modulating postoral processes in… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Meal, Obesity, Morbid, Food Deprivation
- What is being tested?
- Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2018to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult females with severe obesity and scheduled to undergo RYGB
Who may be able to join
- ability to provide inform consent
- treatment group: scheduled for RYGB for severe obesity
- control group: normal weight, healthy general condition
Who cannot join
- lactose intolerance
- diabetes
- immunosuppression
- pregnancy / lactation
- use of weight-loss medication
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Microstructural Analysis of Ingestive Behavior After Roux-en-Y Gastric Bypass - a Prospective Controlled Exploratory Pilot Study Using a Novel Drinkometer to Measure Liquid Lunch Intake
The ability to assess ingestion in fine detail over the time course of a liquid meal allows for comparison of early and late meal features of drinking and may help dissociate manipulations (surgical, neural, pharmacological, etc.) that affect orosensory properties from those that are modulating postoral processes in the control of intake.
The aim of the study is to asses microstructural changes in liquid meal intake over 1-year in severely obese patients after Roux-en-Y gastric bypass (RYGB).
Read the detailed description
Introduction
Bariatric surgery (BS) is currently the most effective treatment of severe obesity. BS has a pleiotropic effect on the body, involving changes in basic metabolic rate, gut hormone and bile acid levels, intestinal nerve signaling and microbiota composition. Overall, patients report to eat less, to feel less hungry and they often change their taste preferences. Initial insights on food intake and appetite can be provided by indirect measures such as verbal report of energy intake, food diaries, and dietary recall questionnaires. However, indirect measures are vulnerable to inaccuracy and, at best, only offer an estimate of the target behavior. Such methodological limitations can be improved by complementing existing findings with direct measures of feeding and drinking. There are only very few studies to date that have applied direct measures of ingestive behavior in BS patients. These studies focused mainly on macronutrient composition within a cafeteria diet and on some motivational aspects of appetite behavior. This might be due to the fact that the assessment of the temporal organization of ingestive behavior within a meal in humans poses significant methodological and conceptual challenges to researchers and study design. The investigators have recently developed and validated a novel drinkometer for humans, which may have great utility in investigations of the specific behavioral variables that underlie the dysregulation of appetite control in morbid obesity, and also to specify neural effects of various medical or surgical weight-loss interventions.
The aim of this exploratory pilot study is to observe the ingestive microstructure of a liquid meal intake before and several occasions after RYGB. Observed values may serve as basis for designing future observational studies in the field of obesity research.
Methods
Prospective observational controlled cohort pilot study in severely obese patients scheduled for RYGB. 11 patients and 10 normal-weight controls will be recruited to consume a calorically dense standardized refrigerated liquid meal (product: Resource 2.0+fibre, Nestle, Vevey, Switzerland) in a food deprived state, until reaching satiety. The novel drinkometer will be used to measure ingestive microstructure and overall intake, and anthropometric parameters (weight, height) will be measured as well. Visual analogue scales will be used to assess self-reported hunger, thirst, fullness, taste preference and participants will estimate their intake at the end of each session. Time points for patients: pre-operatively, postoperative 1 week, 1-3-6-12 months. Time points for control group: baseline, 1-3-12 months. Due to major differences in ingestive microstructure, only female participants will be included in the study.
Satistical analysis
The drinkometer data will be processed and filtered by an in-house developed algorithm in Matlab 2017 software. Results will be analysed using descriptive statistics, as well as ANOVA, t-tests and Wilcoxon signed rank test in R software version 3.5.1.
Potential outcomes
Any comprehensive understanding of how BS affects food intake requires a detailed analysis of the ingestive behavior itself, not simply the measurement of the outcome of the behavior. In other words, the information on how the food is consumed is equally or even more important than the information on how much food has been ingested. To the best of our knowledge, this is the first time that drinking microstructure in humans will be recorded and analyzed after BS. Results will inform on the range of values that can be observed in this patient population and will serve as a basis to accurately power future studies in this field. Further, this exploratory study may generate hypothesis on behavioral changes that occur following BS. Any treatment that affects total intake - e.g. BS - can be entirely viewed as function of its single components such as size and number of sucking bursts which then can provide relevant information e.g. on the motivational aspects of the ingestive behavior. The investigators expect to find no difference in the ingestive behavior between patients before and after RYGB and in comparison to lean controls when the high-sugar high-fat stimulus is consumed for the first time. The investigators also do not expect an effect of RYGB on the number of sucking events within the first minute of the test session. As initial suck rate reflects the consummatory behavior in response to a given stimulus and thus indicate the initial motivational state toward this stimulus, the lack of RYGB-induced changes in this microstructural parameter would suggest that RYGB does not change the palatability of the stimulus. In line with this, the investigators further expect that suck rate during consumption of the fluid will decrease as a function of meal progress and with progressing postoperative time in patients after RYGB, but not in lean controls. Regardless of which outcomes are obtained, this innovative experiment will be a critical and a novel test of the explicit experience of humans with a high-sugar high-fat liquid meal after RYGB and its potential role for the understanding possible mechanisms determining postoperative outcomes, such as weight loss.
- Conditions
- Meal, Obesity, Morbid, Food Deprivation, Bariatric Surgery, Roux-en-y Gastric Bypass, Ingestive Microstructure
- Being tested
- Roux-en-Y gastric bypass
- Medical subject headings
- Obesity, Morbid, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypassProcedure or surgery
laparoscopic surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y gastric bypass patients | severely obese non-diabetic adult female patients scheduled for RYGB Receives: Procedure: Roux-en-Y gastric bypass | |
| Normal weight controls | normal weight healthy non-diabetic adult females | |
| Obese controls | Severely obese non-diabetic adult female patients not scheduled for RYGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in microstructure of ingestive behavior of 1 liquid meal
recording of meal intake by the drinkometer
Measured: baseline, 1 week, 1-3-6-12 months
Secondary outcomes (2)
change in self-reported hunger, thirst, fullness, taste preference, estimated consumption
visual analogue scale (0-100 mm, higher number refer to stronger feeling/higher liking)
Measured: baseline, 1 week, 1-3-6-12 months
body mass index
weight/height measurements
Measured: baseline, 1 week, 1-3-6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MealStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Bueter
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Psychology and Program in Neuroscience, Florida State University, Tallahassee, FL, USA
- Responsible party
- Sponsor-investigator, Marco Bueter, University of Zurich
- Investigators
- Marco Bueter, MD, PhD, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747445
- Sponsor's protocol ID
- 2017-00756-2
- Other IDs
- 2017
- Status last verified
- Jun 2021
- First submitted
- 16 Nov 2018
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gero 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, Steinert RE, le Roux CW, Bueter M. Do Food Preferences Change After Bariatric Surgery? Curr Atheroscler Rep. 2017 Sep;19(9):38. doi: 10.1007/s11883-017-0674-x.
PubMed 28779431Mathes CM, Bohnenkamp RA, Blonde GD, Letourneau C, Corteville C, Bueter M, Lutz TA, le Roux CW, Spector AC. Gastric bypass in rats does not decrease appetitive behavior towards sweet or fatty fluids despite blunting preferential intake of sugar and fat. Physiol Behav. 2015 Apr 1;142:179-88. doi: 10.1016/j.physbeh.2015.02.004. Epub 2015 Feb 3.
PubMed 25660341Spector AC, Klumpp PA, Kaplan JM. Analytical issues in the evaluation of food deprivation and sucrose concentration effects on the microstructure of licking behavior in the rat. Behav Neurosci. 1998 Jun;112(3):678-94. doi: 10.1037//0735-7044.112.3.678.
PubMed 9676983Johnson AW. Characterizing ingestive behavior through licking microstructure: Underlying neurobiology and its use in the study of obesity in animal models. Int J Dev Neurosci. 2018 Feb;64:38-47. doi: 10.1016/j.ijdevneu.2017.06.012. Epub 2017 Jul 3.
PubMed 28684308Gero 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 34369388
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microstructural Analysis of Ingestive Behavior After Roux-en-Y Gastric Bypass - a Prospective Controlled Exploratory Pilot Study Using a Novel Drinkometer to Measure Liquid Lunch Intake
- ClinicalTrials.gov ID
- NCT03747445
- Acronym / sponsor ID
- 2017-00756-2
- Conditions
- Meal, Obesity, Morbid, Food Deprivation, Bariatric Surgery, Roux-en-y Gastric Bypass, Ingestive Microstructure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marco BueterUniversity, hospital or other
- Collaborators
- Department of Psychology and Program in Neuroscience, Florida State University, Tallahassee, FL, USA
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 20 Nov 2018 (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 ability to assess ingestion in fine detail over the time course of a liquid meal allows for comparison of early and late meal features of drinking and may help dissociate manipulations (surgical, neural, pharmacological, etc.) that affect orosensory properties from those that are modulating postoral processes in the control of intake.
The aim of the study is to asses microstructural changes in liquid meal intake over 1-year in severely obese patients after Roux-en-Y gastric bypass (RYGB).
Detailed description
Introduction
Bariatric surgery (BS) is currently the most effective treatment of severe obesity. BS has a pleiotropic effect on the body, involving changes in basic metabolic rate, gut hormone and bile acid levels, intestinal nerve signaling and microbiota composition. Overall, patients report to eat less, to feel less hungry and they often change their taste preferences. Initial insights on food intake and appetite can be provided by indirect measures such as verbal report of energy intake, food diaries, and dietary recall questionnaires. However, indirect measures are vulnerable to inaccuracy and, at best, only offer an estimate of the target behavior. Such methodological limitations can be improved by complementing existing findings with direct measures of feeding and drinking. There are only very few studies to date that have applied direct measures of ingestive behavior in BS patients. These studies focused mainly on macronutrient composition within a cafeteria diet and on some motivational aspects of appetite behavior. This might be due to the fact that the assessment of the temporal organization of ingestive behavior within a meal in humans poses significant methodological and conceptual challenges to researchers and study design. The investigators have recently developed and validated a novel drinkometer for humans, which may have great utility in investigations of the specific behavioral variables that underlie the dysregulation of appetite control in morbid obesity, and also to specify neural effects of various medical or surgical weight-loss interventions.
The aim of this exploratory pilot study is to observe the ingestive microstructure of a liquid meal intake before and several occasions after RYGB. Observed values may serve as basis for designing future observational studies in the field of obesity research.
Methods
Prospective observational controlled cohort pilot study in severely obese patients scheduled for RYGB. 11 patients and 10 normal-weight controls will be recruited to consume a calorically dense standardized refrigerated liquid meal (product: Resource 2.0+fibre, Nestle, Vevey, Switzerland) in a food deprived state, until reaching satiety. The novel drinkometer will be used to measure ingestive microstructure and overall intake, and anthropometric parameters (weight, height) will be measured as well. Visual analogue scales will be used to assess self-reported hunger, thirst, fullness, taste preference and participants will estimate their intake at the end of each session. Time points for patients: pre-operatively, postoperative 1 week, 1-3-6-12 months. Time points for control group: baseline, 1-3-12 months. Due to major differences in ingestive microstructure, only female participants will be included in the study.
Satistical analysis
The drinkometer data will be processed and filtered by an in-house developed algorithm in Matlab 2017 software. Results will be analysed using descriptive statistics, as well as ANOVA, t-tests and Wilcoxon signed rank test in R software version 3.5.1.
Potential outcomes
Any comprehensive understanding of how BS affects food intake requires a detailed analysis of the ingestive behavior itself, not simply the measurement of the outcome of the behavior. In other words, the information on how the food is consumed is equally or even more important than the information on how much food has been ingested. To the best of our knowledge, this is the first time that drinking microstructure in humans will be recorded and analyzed after BS. Results will inform on the range of values that can be observed in this patient population and will serve as a basis to accurately power future studies in this field. Further, this exploratory study may generate hypothesis on behavioral changes that occur following BS. Any treatment that affects total intake - e.g. BS - can be entirely viewed as function of its single components such as size and number of sucking bursts which then can provide relevant information e.g. on the motivational aspects of the ingestive behavior. The investigators expect to find no difference in the ingestive behavior between patients before and after RYGB and in comparison to lean controls when the high-sugar high-fat stimulus is consumed for the first time. The investigators also do not expect an effect of RYGB on the number of sucking events within the first minute of the test session. As initial suck rate reflects the consummatory behavior in response to a given stimulus and thus indicate the initial motivational state toward this stimulus, the lack of RYGB-induced changes in this microstructural parameter would suggest that RYGB does not change the palatability of the stimulus. In line with this, the investigators further expect that suck rate during consumption of the fluid will decrease as a function of meal progress and with progressing postoperative time in patients after RYGB, but not in lean controls. Regardless of which outcomes are obtained, this innovative experiment will be a critical and a novel test of the explicit experience of humans with a high-sugar high-fat liquid meal after RYGB and its potential role for the understanding possible mechanisms determining postoperative outcomes, such as weight loss.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y gastric bypass patients | – | Procedure: Roux-en-Y gastric bypassseverely obese non-diabetic adult female patients scheduled for RYGB |
| Normal weight controls | – | –normal weight healthy non-diabetic adult females |
| Obese controls | – | –Severely obese non-diabetic adult female patients not scheduled for RYGB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult females with severe obesity and scheduled to undergo RYGB
Key inclusion criteria (3 listed)
- ability to provide inform consent
- treatment group: scheduled for RYGB for severe obesity
- control group: normal weight, healthy general condition
Key exclusion criteria (5 listed)
- lactose intolerance
- diabetes
- immunosuppression
- pregnancy / lactation
- use of weight-loss medication
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 |
|---|---|---|
| Roux-en-Y gastric bypasslaparoscopic surgical procedure | Procedure or surgery | Roux-en-Y gastric bypass patients |
Primary outcome
change in microstructure of ingestive behavior of 1 liquid meal
Time frame: baseline, 1 week, 1-3-6-12 months
recording of meal intake by the drinkometer
2 secondary outcomes
change in self-reported hunger, thirst, fullness, taste preference, estimated consumption
Time frame: baseline, 1 week, 1-3-6-12 months
body mass index
Time frame: baseline, 1 week, 1-3-6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- 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.
- Background: PubMed 28779431Gero D, Steinert RE, le Roux CW, Bueter M. Do Food Preferences Change After Bariatric Surgery? Curr Atheroscler Rep. 2017 Sep;19(9):38. doi: 10.1007/s11883-017-0674-x.
- Background: PubMed 25660341Mathes CM, Bohnenkamp RA, Blonde GD, Letourneau C, Corteville C, Bueter M, Lutz TA, le Roux CW, Spector AC. Gastric bypass in rats does not decrease appetitive behavior towards sweet or fatty fluids despite blunting preferential intake of sugar and fat. Physiol Behav. 2015 Apr 1;142:179-88. doi: 10.1016/j.physbeh.2015.02.004. Epub 2015 Feb 3.
- Background: PubMed 9676983Spector AC, Klumpp PA, Kaplan JM. Analytical issues in the evaluation of food deprivation and sucrose concentration effects on the microstructure of licking behavior in the rat. Behav Neurosci. 1998 Jun;112(3):678-94. doi: 10.1037//0735-7044.112.3.678.
- Background: PubMed 28684308Johnson AW. Characterizing ingestive behavior through licking microstructure: Underlying neurobiology and its use in the study of obesity in animal models. Int J Dev Neurosci. 2018 Feb;64:38-47. doi: 10.1016/j.ijdevneu.2017.06.012. Epub 2017 Jul 3.
- Derived from this study: 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.
- 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.
Marco Bueter, MD, PhD principal investigator
University Hospital, Zürich
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 Meal and Obesity, Morbid, run by Marco Bueter 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in microstructure of ingestive behavior of 1 liquid meal (time frame: baseline, 1 week, 1-3-6-12 months). 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 NCT03747445, which also lists 6 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 11 Jun 2021.