Effect of a Plant-based Ingredient on Generalized Hormonal Responses

Unilever R&D1 site in 1 country12 target enrollmentDecember 2013

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Unilever R&D
Enrollment: 12
Locations: 1
Primary Endpoint: AUC of post-prandial hormones
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

January 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Unilever R&D

Responsible Party

Sponsor

Eligibility Criteria

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;