CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Protein stomach +5 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03466047
NCT03466047N/ACompleted

A Physiological Study on the Effect of Macronutrients Delivery to the Proximal and Distal Small Bowel on Satiety and Gut Hormone Responses

Imperial College London·interventional·Posted Mar 15, 2018·Updated Oct 20, 2020

In Brief

A clinical study evaluating Protein stomach, Protein distal small intestine, and 4 other interventions for Eating Behavior. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEating Behavior
CountriesIreland
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 15, 2018
Enrollment StartMar 15, 2018
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.3 years ago

Interventions

Protein stomachdietary

encapsulated protein stomach

Protein distal small intestinedietary

encapsulated protein distal small intestine

CHO stomachdietary

encapsulated CHO stomach

CHO distal small intestinedietary

encapsulated CHO distal small intestine

Fat stomachdietary

encapsulated Fat stomach

Fat distal small intestinedietary

encapsulated Fat distal small intestine