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

Dialpha

Status: Completed

Conditions: Postprandial Insulinemia; Postprandial Glycemia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: MealShape cinnamon extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02074423

12-026

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

18 participants in 2 patient groups, including a placebo group

MealShape cinnamon extract

Experimental group

Description:

Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread)

Treatment:

Dietary Supplement: MealShape cinnamon extract

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Dietary Supplement: Placebo