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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Postprandial Glycemia, Postprandial Insulinemia

Intervention / Treatment
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* Dietary Supplement: MealShape cinnamon extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 three months preceding the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MealShape cinnamon extract<br>Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread) | Dietary Supplement: MealShape cinnamon extract<br>* Acute administration of 1 g PO (2 capsules of 500 mg)<br>|
| Placebo Comparator: Placebo<br>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) | Dietary Supplement: Placebo<br>* Acute administration of 1 g PO (2 capsules of 500 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 120 minutes compared between MealShape and Placebo after consumption of a standard meal |  | Over 120 minutes after consumption of a standard meal | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cinnamon extract, Postprandial glycemia, Glycemic index, Pre-diabetes, Metabolic syndrome