NCT03911115

Brief Summary

Bariatric surgery is currently considered the most effective treatment for achieving significant, sustained weight loss and reducing comorbidities associated with obesity. Every year in France, more than 55,000 undergo this surgery and nearly 450 000 French have a history of surgery for obesity. The mechanisms of action of bariatric surgery are multiple and are not limited to caloric restriction. Neuro-hormonal effects, changes in the anatomy of the digestive tract, vagal changes or bile circulation have been identified as contributing factors to weight loss and postoperative improvement of comorbidities. In addition, post-operative changes in dietary preferences have also been described, which could contribute to initial weight loss and its maintenance over time (aversion to lipid and sugar products). The counterpart of the rapid and durable efficacy of bariatric surgery is the exposure of patients to a significant risk of protein-energy malnutrition. It should be noted that the protein intake, very limited in the first months after surgery, remains well below the recommended intake after the first postoperative year. Spontaneous consumption of meat and vegetable protein is significantly reduced during the first postoperative month and up to one year after surgery. Apart from the limitation of gastric volume induced by surgery, clinical experience indicates that many patients turn away from protein consumption by aversion. A parallel was made between the significant drop in protein consumption during the first months and the initial loss of lean mass. Thus changes in dietary preferences induced by bariatric surgery could also contribute to postoperative nutritional risk (protein aversion). At the same time, it is noted that olfactory and taste modifications have been reported in previous studies that could be associated with these changes in food preferences. The hypotheses of the current study are that the type of surgery may affect dietary preferences differently after obesity surgery and that surgical failure may be associated with preferences for high fat, high sweet and low protein foods postoperatively for both types of surgery. As far as the investigating team is aware, no study compares dietary preferences between sleeve gastrectomy and gastric bypass using this approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

April 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 24, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

April 5, 2019

Last Update Submit

December 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Food preferences

    Food preferences will be measured using liking score for different food groups.The outcome will be assessed in the period following the bariatric surgery.

    Day 0

Study Arms (1)

Bariatric surgery

Individuals that have undergone a gastric bypass (RYGB) or a sleeve gastrectomy (SG)

Other: Food preference questionnaire

Interventions

This is an online questionnaire administrated once to the participants, to assess food preferences after bariatric surgery. The investigating team will also collect data on the type of surgery, anthropometry, nutrition, taste, smell, disgust and intolerance as well as sociodemographic data.

Bariatric surgery

Eligibility Criteria

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

Patients who have undergone a bariatric surgery, Roux-en-Y Gastric Bypass (RYGB) or sleeve gastrectomy (SG)

You may qualify if:

  • Patient who have undergone a Roux-en-Y Gastric Bypass (RYGB) or a sleeve gastrectomy (SG)
  • Patient aged at least 18

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lyon Sud

Pierre-Bénite, France

Location

Study Officials

  • Erika Guyot, Dr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 10, 2019

Study Start

May 24, 2019

Primary Completion

December 4, 2019

Study Completion

December 4, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Locations