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:

ClinicalTrials.gov Identifier:

NCT01530685

First Posted: February 10, 2012

Last Update Posted: February 10, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Pileje

Purpose

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

Condition	Intervention	Phase
Hyperglycemia	Dietary Supplement: Glycabiane Dietary Supplement: placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Prediabetes

U.S. FDA Resources

Further study details as provided by Pileje:

Primary Outcome Measures:

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


Estimated Enrollment:	60
Study Start Date:	November 2011
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Glycabiane, gelule	Dietary Supplement: Glycabiane 2 gelule per day for 4 months Other Name: Dietary supplement
Placebo Comparator: Placebo	Dietary Supplement: placebo 2 gelules per day for 4 months

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	25 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530685

Contacts


Contact: Karine Clément, Pr	+33 1 42 17 79 19	karine.clement@psl.aphp.fr

Locations


France
CHU Pitié Salpetriere	Recruiting
Paris, France, 75013
Contact: Salwa Rizkalla, Dr +33 1 42 17 79 81 salwa.rizkalla@psl.aphp.fr

Sponsors and Collaborators

Pileje

Investigators


Principal Investigator:	Karine Clément, MD	INSERM U872

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Pileje
ClinicalTrials.gov Identifier:	NCT01530685 History of Changes
Other Study ID Numbers:	PILEJE-Glyca-0910
First Submitted:	December 5, 2011
First Posted:	February 10, 2012
Last Update Posted:	February 10, 2012
Last Verified:	February 2012

Keywords provided by Pileje:


cinnamon chromium prediabete overweight

Additional relevant MeSH terms:


Hyperglycemia Prediabetic State Glucose Metabolism Disorders	Metabolic Diseases Diabetes Mellitus Endocrine System Diseases

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