NCT02074423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

11 months

First QC Date

February 26, 2014

Last Update Submit

February 26, 2014

Conditions

Postprandial GlycemiaPostprandial Insulinemia

Keywords

Cinnamon extractPostprandial glycemiaGlycemic indexPre-diabetesMetabolic syndrome

Outcome Measures

Primary Outcomes (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

    Over 120 minutes after the consumption of a standard meal

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

MealShape cinnamon extract

EXPERIMENTAL

Intake of 2 capsules of 500 mg MealShape 30 minutes before consumption of a standard meal (white bread)

Dietary Supplement: MealShape cinnamon extract

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)

Dietary Supplement: Placebo

Interventions

MealShape cinnamon extractDIETARY_SUPPLEMENT

Acute administration of 1 g PO (2 capsules of 500 mg)

MealShape cinnamon extract
PlaceboDIETARY_SUPPLEMENT

Acute administration of 1 g PO (2 capsules of 500 mg)

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Nutrition Clinique Naturalpha

Lilles, 59020, France

Location

Related Publications (7)

  • 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.

    PMID: 11742409BACKGROUND

  • 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.

    PMID: 22608371BACKGROUND

  • 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.

    PMID: 22093965BACKGROUND

  • 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.

    PMID: 21480806BACKGROUND

  • 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.

    PMID: 17909085BACKGROUND

  • 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.

    PMID: 23102179BACKGROUND

  • 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.

    PMID: 25249234DERIVED

Related Links

MeSH Terms

Conditions

Glucose IntoleranceMetabolic Syndrome

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Xavier Deplanque

    Naturalpha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

February 28, 2014

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

FR(1)