Changes in Ingestive Behaviour Following Gastric Bypass

Sponsor
University of Ulster (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03113305
Collaborator
University College Dublin (Other), University of Florida (Other), Letterkenny University Hospital (Other)
63
2
81.9
31.5
0.4

Study Details

Study Description

Brief Summary

The gastric bypass procedure is known to be one of the most successful treatments for morbid obesity and Type 2 diabetes mellitus, and has been shown to decrease appetite, energy intake, body weight and glycemia both in the short and long term. A number of reports hypothesise that these changes may be driven, at least in part, by positive shifts in food preferences following surgery. However, findings are drawn from self-reported dietary intakes which are beset with measurement bias, thus precluding definite conclusions.

The current work aims to directly observe food intake to test the hypothesis that after gastric bypass food intake changes in a manner which leads to beneficial outcomes on body weight when compared to weight stable control participants. Patients (n=32) with a planned gastric bypass procedure will be recruited from Phoenix Health (Ireland and England) and Letterkenny University Hospital (Ireland), alongside control participants (n=32) with no planned weight loss. All subjects will attend the Human Intervention Studies Unit (HISU), Ulster University on five occasions (1-month pre-surgery and 3, 12, 24 and 60 months post-surgery, with controls being time-matched). Study visits will be fully residential involving two overnight stays within the facility during which participants' 24-hour food intake will be covertly measured (7am-11pm Day 2 and breakfast Day 3) and the following procedures undertakenÍž basal metabolic rate, body composition, bone health, assessment of liking/wanting high fat foods and post-meal gut hormone responses. On each study visit participants will have ad lib access to a range of foods of varying macronutrient composition and which are compatible with their stated food preferences (assessed prior to the start of the study). Changes in all ingestive behaviours will be evaluated over time as compared to the control participants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    63 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Changes in Ingestive Behaviour Following Gastric Bypass
    Actual Study Start Date :
    Sep 1, 2016
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Gastric bypass patients

    Patients planned to undergo Gastric bypass procedure. Patients will be assessed -1 month, 3-, 24-, 48- and 60 months post surgery.

    Healthy controls

    Healthy controls with no planned weight loss/gain. Control participant assessments will be time-matched with patients.

    Outcome Measures

    Primary Outcome Measures

    1. Food intake [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Total energy density (kJ / gram)

    Secondary Outcome Measures

    1. Total energy intake [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      24-hour intake (kJ)

    2. Relative macronutrient intake [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      % contribution of macronutrient to energy intake

    3. Food preferences [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Explicit and implicit food preferences measured by the Leeds Food Preference Questionnaire

    4. Eating occasion size [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Grams and kJ over 24 hour period

    5. Eating speed [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      g/min and kJ/min over 24 hour period

    6. Meal frequency [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Defined as a continuous period of feeding terminated with a pause >5mins

    7. Basal Metabolic Rate [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Measured by indirect calorimetry

    8. Percentage body fat [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Measured by dual X-ray absorptiometry

    9. Percentage lean weight [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Measured by dual X-ray absorptiometry

    10. Bone health [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

      Measured by dual X-ray absorptiometry

    11. Serum lipid profile [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

    12. Plasma micronutrient status [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

    13. Serum C-Reactive Protein [Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 years

    • Planned gastric bypass surgery (patients only)

    • No planned weight loss/gain (controls only)

    Exclusion Criteria:

    Patients

    • Significant dysphagia, gastric outlet obstruction or any other factor which prevents consumption of a meal

    • Systemic or gastrointestinal condition which may affect food intake or preference

    • Pregnancy / lactation

    • Significant food allergy or dietary restriction

    • Medication with documented effect on food intake or food preference

    • Any other physical or psychological condition which would affect the outcome of the study as determined by Phoenix Health care team.

    Controls

    • Medication with documented effect on food intake / preference or study outcomes

    • Pregnancy / lactation

    • Significant food allergy or dietary restriction

    • Undertaking a weight-loss programme or planning to.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Letterkenny University Hospital Letterkenny Ireland
    2 Human Intervention Studies Unit, Ulster University Coleraine Co.Londonderry United Kingdom BT52 1SA

    Sponsors and Collaborators

    • University of Ulster
    • University College Dublin
    • University of Florida
    • Letterkenny University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Ulster
    ClinicalTrials.gov Identifier:
    NCT03113305
    Other Study ID Numbers:
    • 16/WS/0056
    First Posted:
    Apr 13, 2017
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Ulster
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022