Clinical trial NCT02003586: Effect of a Plant-based Ingredient on Generalized Hormonal Responses
Official title: Effect of a Plant-based Ingredient on Generalized Hormonal Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: subjects
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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;
* 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.

Primary outcomes:
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
measure: AUC of post-prandial hormones
timeFrame: 120 minutes
Secondary outcomes:
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
measure: AUC of post-prandial hormones
timeFrame: 180 and 240 minutes
Other outcomes:
measure: Blood glucose response (+iAUC)
timeFrame: 120 and 180 minutes
Locations:
city: Gieres
country: France
facility: Eurofins Optimed Clinical research
Study officials:
affiliation: EUROFINS OPTIMED, GIERES - France
name: Yves DONAZZOLO, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: