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CompletedNCT01530685Updated Apr 20, 2021

Gycabiane and Glycemic Control of Prediabetic Subjects

An interventional study of Glycabiane and placebo in Hyperglycemia, sponsored by PiLeJe. Completed at 1 site in France. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by PiLeJe · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hyperglycemia

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Keywords

  • cinnamon
  • chromium
  • prediabete
  • overweight
03

In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's enrollment of 83 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

PiLeJe is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    Glycabiane, gelule

    Dietary Supplement: Glycabiane

  • Placebo comparator
    Placebo

    Dietary Supplement: placebo

Interventions

  • Dietary supplementGlycabiane

    2 gelule per day for 4 months

    Also known as: Dietary supplement

  • Dietary supplementplacebo

    2 gelules per day for 4 months

06

What researchers measure

Primary outcomes

  1. Fast Blood Glucose

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

    Time frame: 4 months

07

Study locations

1 site
  • CHU Pitié Salpetriere
    Paris, 75013, France
08

References and documents

Publications

  • 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 Dec 14;10(12):e0145315. doi: 10.1371/journal.pone.0145315. PubMed 26406981 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01530685
Lead sponsor
PiLeJe
Responsible party
Sponsor
First posted
Feb 10, 2012
Start date
Oct 27, 2011
Primary completion
Sep 25, 2012
Completion
Sep 25, 2012
Last update
Apr 20, 2021

Study contacts

Karine Clément, MD
principal investigator · INSERM U872

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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