Postprandial Glycemia, Postprandial Insulinemia
Conditions
Keywords
Cinnamon extract, Postprandial glycemia, Glycemic index, Pre-diabetes, Metabolic syndrome
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.
Interventions
DIETARY_SUPPLEMENTMealShape cinnamon extract
Acute administration of 1 g PO (2 capsules of 500 mg)
DIETARY_SUPPLEMENTPlacebo
Acute administration of 1 g PO (2 capsules of 500 mg)
Sponsors
Dialpha
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Evaluation of the safety of MealShape with adverse events recording | 3 weeks |
Countries
France
Outcome results
None listed