N/A N=8 Randomized Double-blind Basic Science

The Effect of Macronutrients on Satiety and Gut Hormone Responses

Eating Behavior

Bottom Line

View on ClinicalTrials.gov: NCT03466047 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract — 1310; 1073; 1118; 1188 pg*min/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 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 (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY The Effect of Proteins on the Secretion of Gut Hormones From Different Parts of the Gastrointestinal Tract	1310; 1073; 1118; 1188; 1725; 1194	—
SECONDARY Total Intake (kj) of ad Libitum Lunch Meals to Assess Food Intake	3138; 3389; 3146; 3008; 3690; 2305	—
SECONDARY Visual Analogue Scale Ratings of Hunger	5.4; 5.5; 3.8; 4.1; 4.1; 4.1	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03466047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.