The Effect of Macronutrients on Satiety and Gut Hormone Responses
Microcapsule
A Physiological Study on the Effect of Macronutrients Delivery to the Proximal and Distal Small Bowel on Satiety and Gut Hormone Responses
1 other identifier
interventional
8
1 country
1
Brief Summary
This study is part of a research theme aiming at elucidating the physiological mechanisms of action of weight loss after gastric bypass surgery. The Roux-en-Y Gastric Bypass procedure induces pronounced and sustained weight loss, but the physiological mechanisms of action are not completely clear. Neither mechanical restriction of food intake nor malabsorption, are the main contributing factors. The enhanced postprandial responses of gut hormones (e.g. GLP-1 and PYY) which increase satiety as well as energy expenditure after surgery suggest a changed physiological set point for appetite and metabolism. Our hypothesis is that the intake of high quantity of protein in a microcapsule form would be able to reach the distal parts of the intestinal mucosa and stimulate maximum stimulation of the anorectic gut hormones. The higher functions of the brain will respond to these strong neuroendocrine signals by ensuing satiety and fullness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedStudy Start
First participant enrolled
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedResults Posted
Study results publicly available
October 20, 2020
CompletedOctober 20, 2020
September 1, 2020
10 months
March 3, 2018
August 7, 2020
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract
3 hours AUC for different gut hormones (PYY) to determine the response to macronutrients in different release (stomach vs small intestine) locations. AUC for timepoints 0, 30min, 60min, 120min, 180min.
3 hours
Secondary Outcomes (2)
Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake
3 hours
Visual Analogue Scale Ratings of Hunger
180min
Study Arms (6)
Protein stomach
EXPERIMENTALEncapsulated protein released in the stomach
Protein distal small intestine
EXPERIMENTALEncapsulated protein released in the distal small intestine
CHO stomach
EXPERIMENTALEncapsulated CHO released in the stomach
CHO distal small intestine
EXPERIMENTALEncapsulated CHO released in the distal small intestine
Fat stomach
EXPERIMENTALEncapsulated Fat released in the stomach
Fat distal small intestine
EXPERIMENTALEncapsulated Fat released in the distal small intestine
Interventions
encapsulated protein distal small intestine
encapsulated CHO distal small intestine
encapsulated Fat distal small intestine
Eligibility Criteria
You may qualify if:
- years
- Normal fasting glucose
- Stable body weight for at least last three months
- BMI \< 30 Kg/m2
- Capacity to consent to participate
- Independently mobile
You may not qualify if:
- Patients who meet any of the following criteria will be excluded:
- Pre-diabetes Diabetes
- Obesity
- Smoking
- Substance abuse
- Pregnancy
- Use of medications (except for oral contraceptives)
- Chronic medical or psychiatric illness
- Any significant abnormalities detected on physical examination, electrocardiography, or screening blood tests (measurement of complete blood count, electrolytes, fasting glucose, and liver function)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Centre
Dublin, Dublin 4, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carel le Roux
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Carel le Roux
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 3, 2018
First Posted
March 15, 2018
Study Start
March 15, 2018
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
October 20, 2020
Results First Posted
October 20, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share