Clinical trial NCT03363581: Food Preference Following Bariatric Surgery
Official title: Food Preference Following Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Food preferences
Fat
Weight loss
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity attending a specialist obesity clinic and free living individuals.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Food Intake (Lunch Buffet) at 24 Months
timeFrame: 24 months
measure: Change in Absolute Intake of Fat
timeFrame: 24 months
measure: Change in Absolute Intake of Carbohydrates
timeFrame: 24 months
measure: Change in Absolute Intake of Sugar
timeFrame: 24 months
measure: Change in Absolute Intake of Protein
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: Imperial College London
name: Carel le Roux, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References: