Effect of a Plant-based Ingredient on Generalized Hormonal Responses

NCT ID: NCT02003586

Last Updated: 2014-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-01-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Plant-based ingredient to a starchy meal

Plant-based ingredient

Group Type: OTHER

plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

No plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Starchy meal alone

No plant-based ingredient

Group Type: OTHER

plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

No plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

Interventions

plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

No plant-based ingredient

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves DONAZZOLO, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

EUROFINS OPTIMED, GIERES - France

Locations

Eurofins Optimed Clinical research

Gières, , France

Countries

France

Other Identifiers

FDS-NAA-1462

Identifier Type: -

Identifier Source: org_study_id