Gycabiane and Glycemic Control of Prediabetic Subjects

• ClinicalTrials.gov Identifier: NCT01530685
• Recruitment Status: Unknown
• First Posted: February 10, 2012
• Last Update Posted: February 10, 2012
• Sponsor: Pileje
• Information provided by (Responsible Party): Pileje

Tracking Information

• First Submitted Date: December 5, 2011
• First Posted Date: February 10, 2012
• Last Update Posted Date: February 10, 2012
• Study Start Date: November 2011
• Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2012)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gycabiane and Glycemic Control of Prediabetic Subjects
• Official Title: Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects
• Brief Summary: The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Hyperglycemia

Intervention

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

Study Arms

• Experimental: Glycabiane, gelule
  Intervention: Dietary Supplement: Glycabiane
• Placebo Comparator: Placebo
  Intervention: Dietary Supplement: placebo

• Publications *: 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. eCollection 2015. Erratum in: PLoS One. 2015;10(12):e0145315.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 9, 2012): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2012
• Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01530685
• Other Study ID Numbers: PILEJE-Glyca-0910
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pileje
• Study Sponsor: Pileje
• Collaborators: Not Provided

Investigators

• Principal Investigator: Karine Clément, MD; INSERM U872

• PRS Account: Pileje
• Verification Date: February 2012