NCT03466047

The Effect of Macronutrients on Satiety and Gut Hormone Responses

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Ten healthy volunteers, aged 18 to 65 years will be recruited. Each subject will be studied on six occasions one week apart. On each visit, a baseline serum sample will be drawn from each subject. In a randomized way all subjects will receive the following meals in their successive weekly visits: Option 1 High protein mixed meal in capsules that break down in the stomach, Option 2 High protein mixed meal in capsules that break down in the distal small bowel, Option 3 High fat mixed meal in capsules that break down in the stomach, Option 4 High fat mixed meal in capsules that break down in the distal small bowel, Option 5 High CHD mixed meal in capsules that break down in the stomach, Option 6 High CHD mixed meal in capsules that break down in the distal small bowel. On the same day, all subjects will be offered standard ad libitum meal to measure their food consumption. After 3 hours (i.e. at 12:00) another blood sample will be drawn. All subjects will be asked to rate their appetite on a Visual Analogue Scale (VAS). Upon VAS completion the subjects will be allowed to go home.

Conditions

• Eating Behavior

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protein stomach	encapsulated protein stomach
DIETARY_SUPPLEMENT	Protein distal small intestine	encapsulated protein distal small intestine
DIETARY_SUPPLEMENT	CHO stomach	encapsulated CHO stomach
DIETARY_SUPPLEMENT	CHO distal small intestine	encapsulated CHO distal small intestine
DIETARY_SUPPLEMENT	Fat stomach	encapsulated Fat stomach
DIETARY_SUPPLEMENT	Fat distal small intestine	encapsulated Fat distal small intestine

Timeline

• Start date: 2018-03-15
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2018-03-15
• Last updated: 2020-10-20
• Results posted: 2020-10-20

Locations

1 site across 1 country: Ireland