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OpenTrials
Completed

NCT Number: NCT03363581

Food Preference Following Bariatric Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgical and non-surgical groups:

A) Bariatric surgery B) Controls with no history of bariatric surgery

  • Independently mobile
  • Capacity to consent to participate
  • >18 years of age

Exclusion criteria

  • Pre-operatively: significant dysphagia, gastric outlet obstruction or anything that prevents subjects from eating a meal.
  • Post-operatively: significant and persistent surgical complications or anything that prevents subjects from eating a meal.
  • Systemic or gastrointestinal condition which may affect food intake or preference, including:

i) pregnancy or ii) breast feeding.

  • Active and significant psychiatric illness including substance misuse
  • Significant cognitive or communication issues
  • Medications with documented effect on food intake or food preference
  • History of significant food allergy and certain dietary restrictions
  • History of liver disease or pancreatitis
  • History of bradyarrythmia or congestive cardiac failure group)
  • Use of medications with potential serious interactions with Octreotide

Treatment and study plan

Food preference

Behavioral

Buffet meal to assess food preference

Primary outcomes

  1. Total Food Intake (Lunch Buffet) at 24 Months

    Time frame: 24 months

    Determine the effect of RYGB on total food intake from an ad libitum lunch buffet

  2. Change in Absolute Intake of Fat

    Time frame: 24 months

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of fat from an ad libitum lunch buffet

  3. Change in Absolute Intake of Carbohydrates

    Time frame: 24 months

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of carbohydrates from an ad libitum lunch buffet

  4. Change in Absolute Intake of Sugar

    Time frame: 24 months

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of sugar from an ad libitum lunch buffet

  5. Change in Absolute Intake of Protein

    Time frame: 24 months

    Determine the effect of RYGB on food preferences by measuring the absolute i.e. total intake of protein from an ad libitum lunch buffet

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 6, 2017
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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