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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02074423
Recruitment Status : Completed
First Posted : February 28, 2014
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Dialpha

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postprandial Glycemia Postprandial Insulinemia Dietary Supplement: MealShape cinnamon extract Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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.
Study Start Date : March 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Arm Intervention/treatment
Experimental: MealShape cinnamon extract
Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread)
 Dietary Supplement: MealShape cinnamon extract
Acute administration of 1 g PO (2 capsules of 500 mg)
Placebo Comparator: 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)
 Dietary Supplement: Placebo
Acute administration of 1 g PO (2 capsules of 500 mg)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074423


Locations
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France
Centre de Nutrition Clinique Naturalpha
Lilles, France, 59020
Sponsors and Collaborators
Dialpha
Investigators
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Principal Investigator: Xavier Deplanque Naturalpha
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dialpha
ClinicalTrials.gov Identifier: NCT02074423    
Other Study ID Numbers: 12-026
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014
Keywords provided by Dialpha:
Cinnamon extract
Postprandial glycemia
Glycemic index
Pre-diabetes
Metabolic syndrome