Food Preference Following Bariatric Surgery

• ClinicalTrials.gov Identifier: NCT03363581
• Recruitment Status: Active, not recruiting
• First Posted: December 6, 2017
• Last Update Posted: February 13, 2020
• Sponsor: Imperial College London
• Information provided by (Responsible Party): Carel Le Roux, Imperial College London

Study Description

Brief Summary:

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

Condition or disease	Intervention/treatment
Obesity	Behavioral: Food Preference

Detailed Description:

Roux-en-Y gastric bypass (RYGB) decreases appetite, caloric intake, glycemia, and body weight, all of which are maintained long term.It is controversial whether, after RYGB, patients choose to eat less high fat and sugary foods in favor of lower energy dense alternatives. If true, this could conceivably contribute to improved glycemia and body weight. Disparities among studies on food selection and intake are likely due to the almost complete reliance on self-reported food intake which is vulnerable to inaccuracy.This controversy can best be resolved by complementing existing findings with direct measures of target behaviour in humans. Therefore the proposition to use direct measures in humans after RYGB to test the hypothesis that the selection and intake of foods varying in fat content and glycemic index, as well as the pattern of ingestion within and across meals, changes in a manner that leads to beneficial outcomes on body weight.

Study Design

• Study Type: Observational
• Estimated Enrollment: 70 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Direct Measurement of Food Selection and Intake in Roux- en -Y Gastric Bypass (RYGB) Patients and Normal Weight Controls.
• Actual Study Start Date: December 15, 2017
• Estimated Primary Completion Date: September 30, 2020
• Estimated Study Completion Date: September 30, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
Control; Normal Weight Healthy Controls	Behavioral: Food Preference; Buffet meal to assess food preference
Gastric bypass; Obese patients due to undergo gastric bypass surgery	Behavioral: Food Preference; Buffet meal to assess food preference

Outcome Measures

Primary Outcome Measures :

1. Food Preference [ Time Frame: 24 months ]
   Determine the effect of RYGB on food preference using a standardized Buffet meal.

Secondary Outcome Measures :

1. Gut Hormones [ Time Frame: 2 weeks pre surgery and 3, 12 (two occasions) and 24 months post surgery and matched visits for controls ]
   Determine if the changes in food preference following RYGB are mediated through changes in gut peptide following surgery.
2. Octreotide [ Time Frame: 12 months post surgery and time matched controls at two occasions ]
   Determine the effect of gut hormone suppression (octreotide) on ad libitum macronutrient intake

Biospecimen Retention:   Samples With DNA

Blood- Plasma and Serum

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients with obesity attending a specialist obesity clinic and normal weight controls from the community.

Criteria

Inclusion Criteria:

1. Surgical and non-surgical groups:

   1. Bariatric surgery
   2. Controls with no bariatric surgery.
2. Independently mobile
3. Capacity to consent to participate
4. >18 years of age

Exclusion Criteria:

1. Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
2. Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.

3. Systemic or gastrointestinal condition which may affect food intake or preference, including:

   i) pregnancy or ii) breast feeding.

4. Active and significant psychiatric illness including substance misuse
5. Significant cognitive or communication issues
6. Medications with documented effect on food intake or food preference
7. History of significant food allergy and certain dietary restrictions
8. History of liver disease or pancreatitis (Exclude from Octreotide)
9. History of bradyarrythmia or congestive cardiac failure (Exclude from Octreotide group)
10. Use of medications with potential serious interactions with Octreotide (Exclude from Octreotide group)

Contacts and Locations

Locations

Ireland

University College Dublin

Dublin, Ireland

Sponsors and Collaborators

Imperial College London

Investigators

• Principal Investigator: Carel le Roux, MBChB, PhD; Imperial College London

More Information

• Responsible Party: Carel Le Roux, Reader in Investigative Science, Imperial College London
• ClinicalTrials.gov Identifier: NCT03363581
• Other Study ID Numbers: GutHormoneStudy
• First Posted: December 6, 2017
• Last Update Posted: February 13, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carel Le Roux, Imperial College London:

Food preferences; Fat; Weight loss