A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consumption of Standard Meal

A Randomized, Controlled, Double-blind, Cross-over Clinical Trial, Evaluating the Effect of MealShape™ on the Postprandial Glycemia After Eating Standard Food, in Healthy Volunteers.

The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers.

Inclusion Criteria:

• Healthy male and female volunteers, able to read and write, aged from 18 to 45 years inclusive at time of screening
• Good physical condition
• Body Mass Index (BMI) ≥ 18,5 and < 25 kg/m²
• Written informed consent provided prior to screening, after receiving and understanding the subject information
• Stable body weight (< 5% variation) within the last 3 months prior to screening.
• Subject accepting to keep the same lifestyle throughout the study regarding physical activity, no smoking etc.
• Registered with the French Social Security, in agreement with the French law on biomedical experimentation.

Exclusion Criteria:

• Subject with type 1 or 2 diabetes
• Smoker. Light smoker (less than 5 cigarettes per day) or former smoker (smoking more than 5 cigarettes per day) having stopped less than three months. Smoking (or use of smoking substitute e.g. nicotine patch) is not permitted from screening throughout the study.
• Subject with fasting capillary blood glucose level > 110 mg/dl.
• Subject with fasting capillary blood glucose level ≤ 110 mg/dl and 2 hours postprandial capillary blood glucose level > 140 mg/dl during an Oral Glucose Tolerance Test.
• Subject with any sensitivity or allergy to any of the products used within this clinical trial.
• Intake of product (food and dietary supplement) having an effect on glycemia and insulinemia.
• Intake of all chronic medication excepted oestroprogestative or progestative contraception started at least three months preceding the screening visit.