Metabolic SyndromeNCT01755104
Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome
A study testing Stablor in people with Metabolic Syndrome, run by Laboratoires Nutrition et Cardiometabolisme at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Stablor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2013to Feb 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,
- With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :
- Arterial Blood pressure > or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months,
- Fasting glycemia > or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic < 1.26 g/L,
- Triglycerides > or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months,
- HDL Cholesterol <0.40 g/L or 1.03 mmol/L (males) and <0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months.
Who cannot join
- Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,
- Woman of childbearing potential without an efficient contraception method,
- The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Institut des Nutraceutiques et des Aliments Fonctionnels (INAF)
Laval, Quebec
About this study
Official title: A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome
The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Stablor, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StablorDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Stablor | Experimental | dietary supplement Stablor Receives: Dietary Supplement: Stablor |
| Placebo | Placebo comparator | dietary supplement Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visceral fat area assessed by computerized tomodensitometry
Measured: From baseline to Week 12
Secondary outcomes (2)
Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers
Measured: from baseline to end of study
Quality of life, psychological and behavioral changes
Measured: From baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 Metabolic SyndromeStudies 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Nutrition et Cardiometabolisme
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karine Clement, MD, Principal investigator, Institut CardioMetabolisme et Nutrition (ICAN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755104
- Sponsor's protocol ID
- RCM-EFF-1
- Status last verified
- Mar 2014
- First submitted
- 18 Dec 2012
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bel Lassen P, Belda E, Prifti E, Dao MC, Specque F, Henegar C, Rinaldi L, Wang X, Kennedy SP, Zucker JD, Calame W, Lamarche B, Claus SP, Clement K. Protein supplementation during an energy-restricted diet induces visceral fat loss and gut microbiota amino acid metabolism activation: a randomized trial. Sci Rep. 2021 Aug 2;11(1):15620. doi: 10.1038/s41598-021-94916-9.
PubMed 34341379
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01755104
- Acronym / sponsor ID
- RCM-EFF-1
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Laboratoires Nutrition et CardiometabolismeIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Dec 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 the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stablor | Experimental | Dietary Supplement: Stablordietary supplement Stablor |
| Placebo | Placebo comparator | Dietary Supplement: Placebodietary supplement Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,
- With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :
Key exclusion criteria (3 listed)
- Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,
- Woman of childbearing potential without an efficient contraception method,
- The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial
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 |
|---|---|---|
| Stablor | Dietary supplement | Stablor |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change in visceral fat area assessed by computerized tomodensitometry
Time frame: From baseline to Week 12
2 secondary outcomes
Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers
Time frame: from baseline to end of study
Quality of life, psychological and behavioral changes
Time frame: From baseline to end of study
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 7 Mar 2014.
- Derived from this study: PubMed 34341379Bel Lassen P, Belda E, Prifti E, Dao MC, Specque F, Henegar C, Rinaldi L, Wang X, Kennedy SP, Zucker JD, Calame W, Lamarche B, Claus SP, Clement K. Protein supplementation during an energy-restricted diet induces visceral fat loss and gut microbiota amino acid metabolism activation: a randomized trial. Sci Rep. 2021 Aug 2;11(1):15620. doi: 10.1038/s41598-021-94916-9.
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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 Clement, MD principal investigator
Institut CardioMetabolisme et Nutrition (ICAN)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stablor in people with Metabolic Syndrome, run by Laboratoires Nutrition et Cardiometabolisme at 2 sites in 2 countries.
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 6 inclusion and 3 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 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, 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?
Change in visceral fat area assessed by computerized tomodensitometry (time frame: From baseline to Week 12). 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 NCT01755104, 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 7 Mar 2014.