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

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 Overview

• Status: Completed
• Conditions: Eating Behavior
• Intervention / Treatment: Dietary supplement: Protein stomach; Dietary supplement: Protein distal small intestine; Dietary supplement: CHO stomach; Dietary supplement: CHO distal small intestine; Dietary supplement: Fat stomach; Dietary supplement: Fat distal small intestine

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, Dublin 4
    • Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Protein stomach; Encapsulated protein released in the stomach	Dietary supplement: Protein stomach; encapsulated protein stomach
EXPERIMENTAL: Protein distal small intestine; Encapsulated protein released in the distal small intestine	Dietary supplement: Protein distal small intestine; encapsulated protein distal small intestine
EXPERIMENTAL: CHO stomach; Encapsulated CHO released in the stomach	Dietary supplement: CHO stomach; encapsulated CHO stomach
EXPERIMENTAL: CHO distal small intestine; Encapsulated CHO released in the distal small intestine	Dietary supplement: CHO distal small intestine; encapsulated CHO distal small intestine
EXPERIMENTAL: Fat stomach; Encapsulated Fat released in the stomach	Dietary supplement: Fat stomach; encapsulated Fat stomach
EXPERIMENTAL: Fat distal small intestine; Encapsulated Fat released in the distal small intestine	Dietary supplement: Fat distal small intestine; encapsulated Fat distal small intestine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Carel le Roux, Imperial College London

Publications and helpful links

Helpful Links

• Study publication

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2018
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: March 3, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (ACTUAL): March 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Microcapsule

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No