A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consumption of Standard Meal
Not Applicable
Completed
- Conditions
- Postprandial GlycemiaPostprandial Insulinemia
- Registration Number
- NCT02074423
- Lead Sponsor
- Dialpha
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Blood glucose incremental Area Under the Curve between 0 and 120 minutes after consumption of a standard meal, compared between MealShape and the placebo Over 120 minutes after the consumption of a standard meal
- Secondary Outcome Measures
Name Time Method Blood glucose incremental Area Under the Curve between 0 and 60 minutes compared between MealShape and the placebo after consumption of a standard meal, Over 60 minutes after consumption of a standard meal Capillary blood glucose maximal concentration between MealShape and Placebo after consumption of a standard meal Over 120 minutes after consumption of a standard meal Comparison of glycemia values between MealShape and Placebo at the following time points: T0, T15, T30, T45, T60, T90 and T120 minutes after consumption of a standard meal Over 120 minutes after consumption of a standard meal Evaluation of the safety of MealShape with adverse events recording 3 weeks Insulin incremental Area under the Curve between 0 and 60 minutes compared between MealShape and Placebo after consumption of a standard meal Over 60 minutes after connsumption of a standard meal Insulin incremental Area under the Curve between 0 and 120 minutes compared between MealShape and Placebo after consumption of a standard meal Over 120 minutes after consumption of a standard meal
Trial Locations
- Locations (1)
Centre de Nutrition Clinique Naturalpha
🇫🇷Lilles, France
Centre de Nutrition Clinique Naturalpha🇫🇷Lilles, France