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NCT01530685 Clinical Trial

Gycabiane and Glycemic Control of Prediabetic Subjects

Hyperglycemia Clinical Trial

Official title:
Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01530685
Other study ID # PILEJE-Glyca-0910
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 27, 2011
Est. completion date September 25, 2012

Study information
Verified date April 2021
Source Larena SAS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.

Description:

Cinnamon's effects on blood glucose have been the subject of many clinical and animal studies; however, the issue of cinnamon intake's effect on fasting blood glucose (FBG) in people with prediabetes still remains unclear. The main purpose of this study is to examine the effects of supplementation with Glycabiane, a dietary supplement rich in cinnamon extract, on fast blood glucose of overweight prediabetic subjects in a randomized, placebo-controlled, clinical trial.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date September 25, 2012
Est. primary completion date September 25, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria: - Male or female from 25 to 65 years old - 1.0g/L = fast blood glucose < 1.26g/L - overweight (IMC > 25) Exclusion Criteria: - thyroid disease - hypogonadism - History of musculoskeletal, autoimmune or neurological disease - Treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant - Pregnant or lactating women

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Glycabiane
2 gelule per day for 4 months
• placebo
2 gelules per day for 4 months

Locations
Country Name City State
France CHU Pitié Salpetriere Paris

Sponsors (1)
Lead Sponsor Collaborator
PiLeJe

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fast Blood Glucose Fast blood glucose will be measured before and after 4 months of supplementation and after 2 months of wash-out 4 months
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