Microstructural Analysis of Ingestive Behavior After Roux-en-Y Gastric Bypass - Pilot

June 8, 2021 updated by: Marco Bueter

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).

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 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 Type

Observational

Enrollment (Actual)

30

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
      • Zürich, 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

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Adult females with severe obesity and scheduled to undergo RYGB

Description

Inclusion Criteria:

  • ability to provide inform consent
  • treatment group: scheduled for RYGB for severe obesity
  • control group: normal weight, healthy general condition

Exclusion Criteria:

  • lactose intolerance
  • diabetes
  • immunosuppression
  • pregnancy / lactation
  • use of weight-loss medication

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Roux-en-Y gastric bypass patients
severely obese non-diabetic adult female patients scheduled for RYGB
Procedure: Roux-en-Y gastric bypass
laparoscopic surgical procedure
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 1 week, 1-3-6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in self-reported hunger, thirst, fullness, taste preference, estimated consumption
Time Frame: baseline, 1 week, 1-3-6-12 months
visual analogue scale (0-100 mm, higher number refer to stronger feeling/higher liking)
baseline, 1 week, 1-3-6-12 months
body mass index
Time Frame: baseline, 1 week, 1-3-6-12 months
weight/height measurements
baseline, 1 week, 1-3-6-12 months

Collaborators and Investigators

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

Sponsor

Marco Bueter

Collaborators

Department of Psychology and Program in Neuroscience, Florida State University, Tallahassee, FL, USA

Investigators

  • Principal Investigator: Marco Bueter, MD, PhD, University Hospital, 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)

February 1, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-00756-2

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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