Pharmacokinetics of Plant-based Ingredient

Unilever

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Plant-based ingredient added to starchy meal; Dietary Supplement: No Plant-based ingredient; Dietary Supplement: Plant-based ingredient added to liquid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02168296

FDS-NAA-1602

Details and patient eligibility

About

The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.

Enrollment: 20 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

Exclusion criteria

• Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism
• Any history of gastro-intestinal disorders (including frequent diarrhoea for example)
• 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 intense sporting activities > 10 h/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;
• Allergy or intolerance to food products and aversion to food products;

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 5 patient groups, including a placebo group

No added Plant-based ingredient

Placebo Comparator group

Description:

No Plant-based ingredient added to starchy meal

Treatment:

Dietary Supplement: No Plant-based ingredient

Low dose added to starchy meal

Active Comparator group

Description:

Plant-based ingredient in low dose added to starchy meal

Treatment:

Dietary Supplement: Plant-based ingredient added to starchy meal

High dose added to starchy meal

Active Comparator group

Description:

Plant-based ingredient in high dose added to starchy meal

Treatment:

Dietary Supplement: Plant-based ingredient added to starchy meal

Low dose added to liquid

Active Comparator group

Description:

Plant-based ingredient in low dose added to liquid

Treatment:

Dietary Supplement: Plant-based ingredient added to liquid

High dose added to liquid

Active Comparator group

Description:

Plant-based ingredient in high dose added to liquid

Treatment:

Dietary Supplement: Plant-based ingredient added to liquid