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Gycabiane and Glycemic Control of Prediabetic Subjects

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Glycabiane
placebo
Sponsored by
PiLeJe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring cinnamon, chromium, prediabete, overweight

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Pitié Salpetriere

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glycabiane, gelule

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Fast Blood Glucose
Fast blood glucose will be measured before and after 4 months of supplementation and after 2 months of wash-out

Secondary Outcome Measures

Full Information

First Posted
December 5, 2011
Last Updated
April 19, 2021
Sponsor
PiLeJe
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1. Study Identification

Unique Protocol Identification Number
NCT01530685
Brief Title
Gycabiane and Glycemic Control of Prediabetic Subjects
Official Title
Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2011 (Actual)
Primary Completion Date
September 25, 2012 (Actual)
Study Completion Date
September 25, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PiLeJe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
cinnamon, chromium, prediabete, overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glycabiane, gelule
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Glycabiane
Other Intervention Name(s)
Dietary supplement
Intervention Description
2 gelule per day for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
2 gelules per day for 4 months
Primary Outcome Measure Information:
Title
Fast Blood Glucose
Description
Fast blood glucose will be measured before and after 4 months of supplementation and after 2 months of wash-out
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine Clément, MD
Organizational Affiliation
INSERM U872
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Pitié Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26406981
Citation
Liu Y, Cotillard A, Vatier C, Bastard JP, Fellahi S, Stevant M, Allatif O, Langlois C, Bieuvelet S, Brochot A, Guilbot A, Clement 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.
Results Reference
derived

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Gycabiane and Glycemic Control of Prediabetic Subjects

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