Effect of a Plant-based Ingredient on Generalized Hormonal Responses

Unilever

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: plant-based ingredient; Dietary Supplement: No plant-based ingredient

Study type: Interventional

Funder types: Industry

Identifiers

NCT02003586

FDS-NAA-1462

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Plant-based ingredient to a starchy meal

Other group

Description:

Plant-based ingredient

Treatment:

Dietary Supplement: plant-based ingredient

Dietary Supplement: No plant-based ingredient

Starchy meal alone

Other group

Description:

No plant-based ingredient

Treatment:

Dietary Supplement: plant-based ingredient

Dietary Supplement: No plant-based ingredient