Gycabiane and Glycemic Control of Prediabetic Subjects

April 19, 2021 updated by: PiLeJe

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • CHU Pitie Salpetriere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: placebo
2 gelules per day for 4 months
EXPERIMENTAL: Glycabiane, gelule
Dietary supplement: Glycabiane
2 gelule per day for 4 months
Other Names:
  • Dietary supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PiLeJe

Investigators

  • Principal Investigator: Karine Clément, MD, INSERM U872

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 27, 2011

Primary Completion (ACTUAL)

September 25, 2012

Study Completion (ACTUAL)

September 25, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

February 9, 2012

First Posted (ESTIMATE)

February 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PILEJE-Glyca-0910

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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