A Human Clinical Trial Evaluating the Effect of MealShape™ on Blood Glucose Level Following Consumption of Standard Meal
NCT ID: NCT02074423
Last Updated: 2014-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
18 participants
INTERVENTIONAL
2013-03-31
2014-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MealShape cinnamon extract
Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread)
MealShape cinnamon extract
Acute administration of 1 g PO (2 capsules of 500 mg)
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)
Placebo
Acute administration of 1 g PO (2 capsules of 500 mg)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dialpha
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xavier Deplanque
Role: PRINCIPAL_INVESTIGATOR
Naturalpha
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre de Nutrition Clinique Naturalpha
Lilles, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Guidance on the scientific requirements for health claims related to 2 appetite ratings, weight management, and blood glucose concentrations
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12-026
Identifier Type: -
Identifier Source: org_study_id