Food Preference Following Bariatric Surgery

Obesity Clinical Trial

Official title:

Food Preference Following Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363581
• Other study ID #: GutHormoneStudy
• Status: Completed
• Start date: December 15, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Surgical and non-surgical groups:

A) Bariatric surgery B) Controls with no history of 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

9. History of bradyarrythmia or congestive cardiac failure group)

10. Use of medications with potential serious interactions with Octreotide

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Food Preference
Buffet meal to assess food preference

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Food Intake (Lunch Buffet) at 24 Months	Determine the effect of RYGB on total food intake from an ad libitum lunch buffet	24 months
Primary	Change in Absolute Intake of Fat	Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet	24 months
Primary	Change in Absolute Intake of Carbohydrates	Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet	24 months
Primary	Change in Absolute Intake of Sugar	Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet	24 months
Primary	Change in Absolute Intake of Protein	Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet	24 months