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

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.

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Glycemia; Postprandial Insulinemia
• Intervention / Treatment: Dietary supplement: MealShape cinnamon extract; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lilles, France, 59020
    • Centre de Nutrition Clinique Naturalpha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 120 minutes compared between MealShape and Placebo after consumption of a standard meal	Over 120 minutes after consumption of a standard meal
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

Collaborators and Investigators

• Sponsor: Dialpha

Publications and helpful links

General Publications

• 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. doi: 10.2337/dc07-1711. Epub 2007 Oct 1.
• 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.
• Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
• 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.
• 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.
• 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.
• Beejmohun V, Peytavy-Izard M, Mignon C, Muscente-Paque D, Deplanque X, Ripoll C, Chapal N. Acute effect of Ceylon cinnamon extract on postprandial glycemia: alpha-amylase inhibition, starch tolerance test in rats, and randomized crossover clinical trial in healthy volunteers. BMC Complement Altern Med. 2014 Sep 23;14:351. doi: 10.1186/1472-6882-14-351.

Helpful Links

• Guidance on the scientific requirements for health claims related to 2 appetite ratings, weight management, and blood glucose concentrations

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Postprandial glycemia; Glycemic index; Pre-diabetes; Cinnamon extract
• Other Study ID Numbers: 12-026