Title
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.
Phase
N/ALead Sponsor
DialphaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Postprandial Glycemia Postprandial InsulinemiaIntervention/Treatment
cinnamon ...Study Participants
18The 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.
Acute administration of 1 g PO (2 capsules of 500 mg)
Acute administration of 1 g PO (2 capsules of 500 mg)
Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread)
Intake of 2 capsules of 500 mg placebo, composed of 20% microcrystalline cellulose and 80% dicalcium phosphate, 30 minutes before consumption of a standard meal (white bread)
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.
