Gycabiane and Glycemic Control of Prediabetic Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Pileje.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Pileje
ClinicalTrials.gov Identifier:
NCT01530685
First received: December 5, 2011
Last updated: February 9, 2012
Last verified: February 2012

December 5, 2011
February 9, 2012
November 2011
April 2012   (final data collection date for primary outcome measure)
Fast Blood Glucose [ Time Frame: 4 months ]
Fast blood glucose will be measured before and after 4 months of supplementation and after 2 months of wash-out
Same as current
Complete list of historical versions of study NCT01530685 on ClinicalTrials.gov Archive Site
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Gycabiane and Glycemic Control of Prediabetic Subjects
Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hyperglycemia
  • Dietary Supplement: Glycabiane
    2 gelule per day for 4 months
    Other Names:
    • Glycabiane
    • Dietary supplement
  • Dietary Supplement: placebo
    2 gelules per day for 4 months
    Other Name: Placebo
  • Experimental: Glycabiane, gelule
    Intervention: Dietary Supplement: Glycabiane
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
August 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
25 Years to 65 Years
Yes
Contact: Karine Clément, Pr +33 1 42 17 79 19 karine.clement@psl.aphp.fr
France
 
NCT01530685
PILEJE-Glyca-0910
Not Provided
Pileje
Pileje
Not Provided
Principal Investigator: Karine Clément, MD INSERM U872
Pileje
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP