Microstructure of Ingestive Behavior and Body Weight Loss After Roux-en-Y Gastric Bypass (Drinkometer)

August 14, 2023 updated by: Marco Bueter

Correlation Between Microstructure of Ingestive Behavior and Body Weight Loss in Patients After Roux-en-Y Gastric Bypass

Studies of appetitive behavior in humans after RYGB have produced ambiguous results. It therefore remains unclear whether there are fundamental shifts in the palatability of high-fat and sugary foods after RYGB or simply a decrease in the appetitive drive to ingest them. Moreover, learning processes may play a role as changes in diet selection progress with time in rats after RYGB. However, direct measures of an altered food selection in humans after RYGB are rare and both the durability of the phenomenon as well as the role of experience for changes in food selection remain elusive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 hormones 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 food preferences. Initial insights on food intake and appetite can be provided by indirect measurements such as verbal report of energy intake, food diaries, and dietary recall questionnaires. However, indirect measurements are vulnerable to inaccuracy and, at best, only offer an estimate of the patients' real behavior. Such methodological limitations can be improved by complementing existing findings with direct measurements of eating and drinking. There are only very few studies to date that have applied direct measurements of ingestive behavior in BS patients. These studies focused mainly on macronutrient composition within a cafeteria diet and on some motivational aspects of appetitive 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 drinkometer for humans, which may have great utility in the investigation of the specific behavioral variables that underlie the altered appetite control in obesity, and also to specify neural effects of various medical or surgical weight-loss interventions.

The aim of this exploratory pilot study is to investigate a possible correlation between the microstructure of ingestive behavior and body weight loss in patients after Roux-en-Y gastric bypass with a follow-up of 5 years.

Methods Prospective observational study in patients that already received a RYGB. 50 patients will be recruited to consume a ready-to-drink, energy-dense oral nutritional supplement (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, liking, nausea, and pain. The participants will be asked to estimate their intake at the end of each session. The study visits will take place at each postoperative yearly control visit. Only for one subgroup of 30 patients, one year after surgery, one second study visit will be organised after an interval of two weeks from the first visit. In order to avoid sex-driven major differences in ingestive microstructure, only female participants will be included in the study.

Statistical 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 and statistical tests in RStudio 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 with a five-year follow-up in BS patients. Results will confirm if, in the long term, the microstructure of ingestive behavior might have a correlation with body weight loss or regain and hence be used as a predictor of surgery outcome. 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 at least two type of ingestive behaviours among study participants, one that would correlated with sustained body weight loss and one that would correlate with body weight regain.

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult females with severe obesity that underwent RYGB

Description

Inclusion Criteria:

  • received RYGB
  • ability to provide inform consent

Exclusion Criteria:

  • lactose intolerance
  • diabetes
  • immunosuppression
  • pregnancy / lactation
  • use of weight-loss medication
  • history of previous visceral surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RYGB patients
Patients that already received RYGB one year prior commencement of their participation in the study
Procedure: Roux-en-Y Gastric Bypass
Laparoscopic surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between microstructure of ingestive behavior and body weight loss
Time Frame: one year after surgery
Pearson correlation coefficient for the linear relationship between microstrutural parameters of ingestive behavior and body weight loss one year after RYGB surgery
one year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability of the microstructure of ingestive behavior
Time Frame: fourteen days
Significance of paired difference and equality tests for macrostructural parameters of ingestive behavior of the entire study population measured twice with an interval of fourteen days.
fourteen days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marco Bueter

Collaborators

Dr. Alan Spector, Florida State University, Department of Psychology

Investigators

  • Principal Investigator: Marco Bueter, MD, DPhil, University of Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

July 25, 2020

Study Completion (Actual)

June 4, 2021

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-00756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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