Gycabiane and Glycemic Control of Prediabetic Subjects

NCT ID: NCT01530685

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-27
• Study Completion Date: 2012-09-25

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.

Conditions

Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Glycabiane, gelule

Group Type: EXPERIMENTAL

Glycabiane

Intervention Type: DIETARY_SUPPLEMENT

2 gelule per day for 4 months

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

2 gelules per day for 4 months

Interventions

Glycabiane

2 gelule per day for 4 months

Intervention Type: DIETARY_SUPPLEMENT

placebo

2 gelules per day for 4 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Dietary supplement

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PiLeJe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karine Clément, MD

Role: PRINCIPAL_INVESTIGATOR

INSERM U872

Locations

CHU Pitié Salpetriere

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 26406981 (View on PubMed)

Other Identifiers

PILEJE-Glyca-0910

Identifier Type: -

Identifier Source: org_study_id