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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MealShape cinnamon extract | Experimental | Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread) |
|
| Placebo | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MealShape cinnamon extract | Dietary Supplement | Acute administration of 1 g PO (2 capsules of 500 mg) |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Deplanque | Naturalpha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Nutrition Clinique Naturalpha | Lilles | 59020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11742409 | Background | 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. | |
| 22608371 | Background | 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. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Acute administration of 1 g PO (2 capsules of 500 mg) |
|
| 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 |
| 22093965 | Background | 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. |
| 21480806 | Background | 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. |
| 17909085 | Background | 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. |
| 23102179 | Background | 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. |
| 25249234 | Derived | 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. |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |