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Food Preference Following Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363581
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Carel Le Roux, Imperial College London

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.

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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

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




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


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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363581


Locations
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Ireland
University College Dublin
Dublin, Ireland
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Carel le Roux, MBChB, PhD Imperial College London
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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    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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