NCT01530685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2012

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

December 5, 2011

Last Update Submit

April 19, 2021

Conditions

Hyperglycemia

Keywords

cinnamonchromiumprediabeteoverweight

Outcome Measures

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

    4 months

Study Arms (2)

Glycabiane, gelule

EXPERIMENTAL
Dietary Supplement: Glycabiane

Placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

GlycabianeDIETARY_SUPPLEMENT

2 gelule per day for 4 months

Also known as: Dietary supplement
Glycabiane, gelule
placeboDIETARY_SUPPLEMENT

2 gelules per day for 4 months

Placebo

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female from 25 to 65 years old
  • g/L ≤ fast blood glucose \< 1.26g/L
  • overweight (IMC \> 25)

You may not qualify if:

  • thyroid disease
  • hypogonadism
  • History of musculoskeletal, autoimmune or neurological disease
  • Treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Pitié Salpetriere

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 26406981DERIVED

MeSH Terms

Conditions

HyperglycemiaOverweight

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Karine Clément, MD

    INSERM U872

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

February 10, 2012

Study Start

October 27, 2011

Primary Completion

September 25, 2012

Study Completion

September 25, 2012

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations

FR(1)