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

Not Applicable

Completed

• Conditions: Postprandial Glycemia; Postprandial Insulinemia
• Interventions: Dietary Supplement: MealShape cinnamon extract; Dietary Supplement: Placebo

• 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

Study Timeline

• Study Start: 2013-03
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-26
• Last Update Submitted: 2014-02-26
• Study First Posted: 2014-02-28
• Last Update Posted: 2014-02-28

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

Arm && Interventions

Group	Intervention	Description
MealShape cinnamon extract	MealShape cinnamon extract	Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread)
Placebo	Placebo	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)

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