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Gycabiane and Glycemic Control of Prediabetic Subjects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
No Changes Posted
Not Provided
Not Provided
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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 Name: Dietary supplement
  • Dietary Supplement: placebo
    2 gelules per day for 4 months
  • Experimental: Glycabiane, gelule
    Intervention: Dietary Supplement: Glycabiane
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: placebo
Liu Y, Cotillard A, Vatier C, Bastard JP, Fellahi S, Stévant M, Allatif O, Langlois C, Bieuvelet S, Brochot A, Guilbot A, Clément K, Rizkalla SW. A Dietary Supplement Containing Cinnamon, Chromium and Carnosine Decreases Fasting Plasma Glucose and Increases Lean Mass in Overweight or Obese Pre-Diabetic Subjects: A Randomized, Placebo-Controlled Trial. PLoS One. 2015 Sep 25;10(9):e0138646. doi: 10.1371/journal.pone.0138646. Erratum in: PLoS One. 2015;10(12):e0145315.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01530685
PILEJE-Glyca-0910
Not Provided
Not Provided
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