The Effect of Macronutrients on Satiety and Gut Hormone Responses

Eating Behavior Clinical Trial

— Microcapsule  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466047
• Other study ID #: Microcapsule
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: September 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years

• Normal fasting glucose

• Stable body weight for at least last three months

• BMI < 30 Kg/m2

• Capacity to consent to participate

• Independently mobile

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Dietary Supplement:
• Protein stomach
encapsulated protein stomach
• Protein distal small intestine
encapsulated protein distal small intestine
• CHO stomach
encapsulated CHO stomach
• CHO distal small intestine
encapsulated CHO distal small intestine
• Fat stomach
encapsulated Fat stomach
• Fat distal small intestine
encapsulated Fat distal small intestine

Locations

Country	Name	City	State
Ireland	Clinical Research Centre	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake	Food intake as assessed with ad libitum lunch 3 hours after intervention	3 hours
Secondary	Visual Analogue Scale Ratings of Hunger	Visual Analogue Scale ratings of hunger at 180 min (before the meal). The scale is 10cm line with two anchors at each end. Scores are recorded by making a handwritten mark that represents a continuum between "not hungry at all" and "Extremly hungry."; The score of 0 represents least hunger. The score of 10 represent extreme hunger.	180min

External Links

•   Study publication