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

Postprandial Glycemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074423
• Other study ID #: 12-026
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: February 26, 2014
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Dialpha
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postprandial Glycemia
• Postprandial Insulinemia

Intervention

Dietary Supplement:
• MealShape cinnamon extract
Acute administration of 1 g PO (2 capsules of 500 mg)
• Placebo
Acute administration of 1 g PO (2 capsules of 500 mg)

Locations

Country	Name	City	State
France	Centre de Nutrition Clinique Naturalpha	Lilles

Sponsors (1)

Lead Sponsor	Collaborator
Dialpha

Country where clinical trial is conducted

France, 

References & Publications (6)

Baker WL, Gutierrez-Williams G, White CM, Kluger J, Coleman CI. Effect of cinnamon on glucose control and lipid parameters. Diabetes Care. 2008 Jan;31(1):41-3. Epub 2007 Oct 1. — View Citation

Davis PA, Yokoyama W. Cinnamon intake lowers fasting blood glucose: meta-analysis. J Med Food. 2011 Sep;14(9):884-9. doi: 10.1089/jmf.2010.0180. Epub 2011 Apr 11. Review. — View Citation

Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026. — View Citation

Magistrelli A, Chezem JC. Effect of ground cinnamon on postprandial blood glucose concentration in normal-weight and obese adults. J Acad Nutr Diet. 2012 Nov;112(11):1806-9. doi: 10.1016/j.jand.2012.07.037. — View Citation

Rafehi H, Ververis K, Karagiannis TC. Controversies surrounding the clinical potential of cinnamon for the management of diabetes. Diabetes Obes Metab. 2012 Jun;14(6):493-9. doi: 10.1111/j.1463-1326.2011.01538.x. Epub 2011 Dec 27. Review. — View Citation

Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Capillary blood glucose maximal concentration between MealShape and Placebo after consumption of a standard meal		Over 120 minutes after consumption of a standard meal	No
Secondary	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	No
Secondary	Evaluation of the safety of MealShape with adverse events recording		3 weeks	Yes
Secondary	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	No
Secondary	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	No

External Links

•   Guidance on the scientific requirements for health claims related to 2 appetite ratings, weight management, and blood glucose concentrations
•   International Diabetes Federation: Guideline for management of postmeal glucose (2007)
•   World Health Organization (2006) Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia : report of a WHO/IDF consultation