HyperglycemiaNCT01530685
Gycabiane and Glycemic Control of Prediabetic Subjects
A study testing Glycabiane in people with Hyperglycemia, run by PiLeJe at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Glycabiane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2011to 25 Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female from 25 to 65 years old
- 1.0g/L ≤ fast blood glucose < 1.26g/L
- overweight (IMC > 25)
Who cannot join
- thyroid disease
- hypogonadism
- History of musculoskeletal, autoimmune or neurological disease
- Treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Hyperglycemia
- Being tested
- Glycabiane, placebo
- Keywords
- cinnamon, chromium, prediabete, overweight
- Medical subject headings
- Hyperglycemia, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycabianeDietary supplement
Also called Dietary supplement
2 gelule per day for 4 months
placeboDietary supplement
2 gelules per day for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Glycabiane, gelule | Experimental | Not described Receives: Dietary Supplement: Glycabiane |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fast Blood Glucose
Fast blood glucose will be measured before and after 4 months of supplementation and after 2 months of wash-out
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study start27 Oct 2011
- Primary completion25 Sep 2012
- Study completion25 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karine Clément, MD, Principal investigator, INSERM U872
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530685
- Sponsor's protocol ID
- PILEJE-Glyca-0910
- Status last verified
- Apr 2021
- First submitted
- 5 Dec 2011
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26406981
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects
- ClinicalTrials.gov ID
- NCT01530685
- Acronym / sponsor ID
- PILEJE-Glyca-0910
- Conditions
- Hyperglycemia
- Keywords
- cinnamon, chromium, prediabete, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2011 (actual)
- Primary completion
- 25 Sep 2012 (actual)
- Study completion
- 25 Sep 2012 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycabiane, gelule | Experimental | Dietary Supplement: Glycabiane |
| Placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female from 25 to 65 years old
- 1.0g/L ≤ fast blood glucose < 1.26g/L
- overweight (IMC > 25)
Key exclusion criteria (5 listed)
- thyroid disease
- hypogonadism
- History of musculoskeletal, autoimmune or neurological disease
- Treatment against thyroid disease, hypoglycemia, hypertension, or anti-coagulant
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycabianeAlso: Dietary supplement2 gelule per day for 4 months | Dietary supplement | Glycabiane, gelule |
| placebo2 gelules per day for 4 months | Dietary supplement | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 26406981Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine Clément, MD principal investigator
INSERM U872
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycabiane in people with Hyperglycemia, run by PiLeJe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fast Blood Glucose (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.