The Effect of Macronutrients on Satiety and Gut Hormone Responses

NCT ID: NCT03466047

Last Updated: 2020-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2019-01-01

Brief Summary

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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

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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

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Eating Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Protein stomach

Encapsulated protein released in the stomach

Group Type EXPERIMENTAL

Protein stomach

Intervention Type DIETARY_SUPPLEMENT

encapsulated protein stomach

Protein distal small intestine

Encapsulated protein released in the distal small intestine

Group Type EXPERIMENTAL

Protein distal small intestine

Intervention Type DIETARY_SUPPLEMENT

encapsulated protein distal small intestine

CHO stomach

Encapsulated CHO released in the stomach

Group Type EXPERIMENTAL

CHO stomach

Intervention Type DIETARY_SUPPLEMENT

encapsulated CHO stomach

CHO distal small intestine

Encapsulated CHO released in the distal small intestine

Group Type EXPERIMENTAL

CHO distal small intestine

Intervention Type DIETARY_SUPPLEMENT

encapsulated CHO distal small intestine

Fat stomach

Encapsulated Fat released in the stomach

Group Type EXPERIMENTAL

Fat stomach

Intervention Type DIETARY_SUPPLEMENT

encapsulated Fat stomach

Fat distal small intestine

Encapsulated Fat released in the distal small intestine

Group Type EXPERIMENTAL

Fat distal small intestine

Intervention Type DIETARY_SUPPLEMENT

encapsulated Fat distal small intestine

Interventions

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Protein stomach

encapsulated protein stomach

Intervention Type DIETARY_SUPPLEMENT

Protein distal small intestine

encapsulated protein distal small intestine

Intervention Type DIETARY_SUPPLEMENT

CHO stomach

encapsulated CHO stomach

Intervention Type DIETARY_SUPPLEMENT

CHO distal small intestine

encapsulated CHO distal small intestine

Intervention Type DIETARY_SUPPLEMENT

Fat stomach

encapsulated Fat stomach

Intervention Type DIETARY_SUPPLEMENT

Fat distal small intestine

encapsulated Fat distal small intestine

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Carel Le Roux

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carel le Roux

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Clinical Research Centre

Dublin, , Ireland

Site Status

Countries

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Ireland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Microcapsule

Identifier Type: -

Identifier Source: org_study_id

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