Effect of a Plant-based Ingredient on Generalized Hormonal Responses

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT02003586
• Lead Sponsor: Unilever R&D

Brief Summary

The study is designed to determine the extent to which foods containing a plant-based ingredient affect blood glucose and hormonal response in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-22
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-06
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy males, Age at start of the study >20 and <50 years;
• Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2;
• Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
• Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
• Agreeing to be informed about medically relevant personal test-results by a physician;
• Informed consent signed;
• Willing to comply to study protocol during study;
• Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
• Accessible veins on arms as determined by examination at screening.

Exclusion Criteria

• Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
• Blood donation in the past 2 months;
• Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
• Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM;
• Reported intense sporting activities > 10h/w;
• Consumption of > 21 alcoholic drinks in a typical week;
• Not being used to eat breakfast;
• Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
• Use of medication which interferes with study measurements;
• Reported dietary habits: medically prescribed diet, slimming diet;
• Not used to eat 3 meals a day;
• Vegetarian;
• Reported weight loss/gain (>10%) in the last six month before the study;
• Being an employee of Unilever and CRO;
• Allergy or intolerance to food products and aversion to food products provided during the study;
• Subject who cannot be contacted in case of emergency;
• Subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
• Subject under guardianship;
• Subject who would receive more than 4500 euro's as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
AUC of post-prandial hormones	120 minutes	Glucagon will be assessed.

Secondary Outcome Measures

Name	Time	Method
AUC of post-prandial hormones	180 and 240 minutes	Glucagon-like peptide-1 (GLP-1) (active) will be assessed.

Trial Locations

Locations (1)

Eurofins Optimed Clinical research; 🇫🇷 Gieres, France