A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consu… (NCT02074423) | Clinical Trial Compass
CompletedNot Applicable
A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consumption of Standard Meal
France18 participantsStarted 2013-03
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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 …
What they're measuring
1
Blood glucose incremental Area Under the Curve between 0 and 120 minutes after consumption of a standard meal, compared between MealShape and the placebo
Timeframe: Over 120 minutes after the consumption of a standard meal