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Completed

NCT Number: NCT03113305

Changes in Ingestive Behaviour Following Gastric Bypass

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 undertaken; 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Letterkenny University Hospital, Letterkenny, Ireland

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Food intake

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

    Total energy density (kJ / gram)

Secondary outcomes

  1. Total energy intake

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

    24-hour intake (kJ)

  2. Relative macronutrient intake

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

    % contribution of macronutrient to energy intake

  3. Food preferences

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

    Measured by indirect calorimetry

  8. Percentage body fat

    Time frame: 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

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

    Measured by dual X-ray absorptiometry

  10. Bone health

    Time frame: 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

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

  12. Plasma micronutrient status

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

  13. Serum C-Reactive Protein

    Time frame: Change from pre-surgery (-1 month) at 3-, 24-, 48- and 60-months post surgery

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2017
Registry last updated
Jun 29, 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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