NCT04933305

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
Last Updated

August 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

June 15, 2021

Last Update Submit

August 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between microstructure of ingestive behavior and body weight loss

    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 Outcomes (1)

  • Stability of the microstructure of ingestive behavior

    fourteen days

Study Arms (1)

RYGB patients

Patients that already received RYGB one year prior commencement of their participation in the study

Procedure: Roux-en-Y Gastric Bypass

Interventions

Laparoscopic surgical procedure

RYGB patients

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult females with severe obesity that underwent RYGB

You may qualify if:

  • received RYGB
  • ability to provide inform consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 30179650BACKGROUND
  • Gero 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.

    PMID: 28779431BACKGROUND
  • Mathes 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.

    PMID: 25660341BACKGROUND
  • Spector 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.

    PMID: 9676983BACKGROUND
  • Johnson 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.

    PMID: 28684308BACKGROUND

MeSH Terms

Conditions

ObesityFeeding Behavior

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Marco Bueter, MD, DPhil

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, PhD, Head of Bariatric and Endocrine Surgery

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 21, 2021

Study Start

April 1, 2019

Primary Completion

July 25, 2020

Study Completion

June 4, 2021

Last Updated

August 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations