The Effect of Macronutrients on Satiety and Gut Hormone Responses

Not Applicable

Completed

• Conditions: Eating Behavior
• Interventions: Dietary Supplement: CHO stomach; Dietary Supplement: Fat distal small intestine; Dietary Supplement: CHO distal small intestine; Dietary Supplement: Protein stomach; Dietary Supplement: Protein distal small intestine; Dietary Supplement: Fat stomach

• Registration Number: NCT03466047
• Lead Sponsor: Imperial College London

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-03-08
• Study Start: 2018-03-15
• Study First Posted: 2018-03-15
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Results First Submitted: 2020-08-07
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-28
• Last Update Submitted: 2020-09-28
• Results First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHO stomach	CHO stomach	Encapsulated CHO released in the stomach
Fat distal small intestine	Fat distal small intestine	Encapsulated Fat released in the distal small intestine
CHO distal small intestine	CHO distal small intestine	Encapsulated CHO released in the distal small intestine
Protein stomach	Protein stomach	Encapsulated protein released in the stomach
Protein distal small intestine	Protein distal small intestine	Encapsulated protein released in the distal small intestine
Fat stomach	Fat stomach	Encapsulated Fat released in the stomach

Primary Outcome Measures

Name	Time	Method
The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract	3 hours	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale Ratings of Hunger	180min	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.
Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake	3 hours	Food intake as assessed with ad libitum lunch 3 hours after intervention

Trial Locations

Locations (1)

Clinical Research Centre; 🇮🇪 Dublin, Ireland