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Completed

NCT Number: NCT02074423

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Nutrition Clinique Naturalpha

Lilles, 59020, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MealShape cinnamon extract

Dietary Supplement

Acute administration of 1 g PO (2 capsules of 500 mg)

Placebo

Dietary Supplement

Acute administration of 1 g PO (2 capsules of 500 mg)

Primary outcomes

  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

    Time frame: Over 120 minutes after the consumption of a standard meal

Secondary outcomes

  1. Blood glucose incremental Area Under the Curve between 0 and 60 minutes compared between MealShape and the placebo after consumption of a standard meal,

    Time frame: Over 60 minutes after consumption of a standard meal

  2. Capillary blood glucose maximal concentration between MealShape and Placebo after consumption of a standard meal

    Time frame: Over 120 minutes after consumption of a standard meal

  3. 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

    Time frame: Over 120 minutes after consumption of a standard meal

  4. Evaluation of the safety of MealShape with adverse events recording

    Time frame: 3 weeks

  5. Insulin incremental Area under the Curve between 0 and 120 minutes compared between MealShape and Placebo after consumption of a standard meal

    Time frame: Over 120 minutes after consumption of a standard meal

  6. Insulin incremental Area under the Curve between 0 and 60 minutes compared between MealShape and Placebo after consumption of a standard meal

    Time frame: Over 60 minutes after connsumption of a standard meal

Sponsors and collaborators

Lead sponsor

Dialpha

Other

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 28, 2014
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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