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
Recruitment status was Recruiting
Sponsor:
Pileje
Information provided by (Responsible Party):
Pileje
ClinicalTrials.gov Identifier:
NCT01530685
First received: December 5, 2011
Last updated: February 9, 2012
Last verified: February 2012
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects |
Resource links provided by NLM:
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 Names:
|
| Placebo Comparator: Placebo |
Dietary Supplement: placebo
2 gelules per day for 4 months
Other Name: Placebo
|
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| Ages Eligible for Study: | 25 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530685
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Pileje |
| ClinicalTrials.gov Identifier: | NCT01530685 History of Changes |
| Other Study ID Numbers: | PILEJE-Glyca-0910 |
| Study First Received: | December 5, 2011 |
| Last Updated: | February 9, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: The Commission nationale de l’informatique et des libertés |
Keywords provided by Pileje:
|
cinnamon chromium prediabete overweight |
ClinicalTrials.gov processed this record on March 03, 2015