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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

Tracking Information
First Submitted Date August 9, 2017
First Posted Date December 6, 2017
Last Update Posted Date February 13, 2020
Actual Study Start Date December 15, 2017
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2017)
Food Preference [ Time Frame: 24 months ]
Determine the effect of RYGB on food preference using a standardized Buffet meal.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 5, 2017)
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Food Preference Following Bariatric Surgery
Official Title Direct Measurement of Food Selection and Intake in Roux- en -Y Gastric Bypass (RYGB) Patients and Normal Weight Controls.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood- Plasma and Serum
Sampling Method Non-Probability Sample
Study Population Patients with obesity attending a specialist obesity clinic and normal weight controls from the community.
Condition Obesity
Intervention Behavioral: Food Preference
Buffet meal to assess food preference
Study Groups/Cohorts
  • Control
    Normal Weight Healthy Controls
    Intervention: Behavioral: Food Preference
  • Gastric bypass
    Obese patients due to undergo gastric bypass surgery
    Intervention: Behavioral: Food Preference
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 5, 2017)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03363581
Other Study ID Numbers GutHormoneStudy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Carel Le Roux, Imperial College London
Study Sponsor Imperial College London
Collaborators Not Provided
Investigators
Principal Investigator: Carel le Roux, MBChB, PhD Imperial College London
PRS Account Imperial College London
Verification Date February 2020