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Metabolic SyndromeOBEMINALE2NCT03692806

Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome

A study testing Stablor in people with Metabolic Syndrome, run by LNC THERAPEUTICS at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
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
240 participants
Where
6 sitesin 2 countries
Study dates
11 Sep 2018to 16 Dec 2020
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female or male
  • Age between 18 and 65 years (limits included),
  • BMI between 27 and 40 kg/m² (limits included),
  • With metabolic syndrome: Waist circumference > 94 cm for male (>90 cm for male of South-East Asian, Chinese and Japanese ethnic groups) and > 80 cm for female and at least two of the following criteria :
  • Triglycerides levels ≥ 1.5 g/L (1.71 mmol/L) or stable under treatment for at least 6 months,
  • HDL cholesterol levels <0.40 g/L (1.03 mmol/L) for male and <0.5 g/l (1.29 mmol/L) for female or stable under treatment for at least 6 months,
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  • Fasting plasma glucose ≥1 g/L (5.6 mmol/L) and non-diabetic,
  • Blood pressure ≥130 mmHg (systolic) and/or 85 mmHg (diastolic) or stable under antihypertensive treatment for at least 6 months,
  • Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
  • Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,

Who cannot join

  • Suffering from a metabolic disorder such as diabetes uncontrolled thyroidal trouble or other metabolic disorder,
  • Suffering from a cardiac insufficiency, inflammatory disease, severe hepatic of renal insufficiency, or gastrointestinal disorders (Crohn's disease or Ulcerative Colitis) or others diseases found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
  • Having suffered of stroke or ictus within the last 6 months,
  • Suffering of depression,
  • Had a major surgical procedure within the last 6 months,
  • Had a bariatric surgery,
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  • With a known or suspected food allergy or intolerance to lactose or soja, or hypersensitivity to any of the study products' ingredient,
  • Who does not like the investigational product flavors "vanilla-toffee", "chocolate" and "coffee",
  • Having a biological selection profile considered as abnormal by the investigator (BUN, Creatinine, calcium, Liver enzymes (GGT, AST, ALT), Blood Cell Count, , HIV, HCV, lipids (TG, HDL, LDL, total cholesterol),glycaemia, B HCG),
  • Pregnant (positive pregnancy test at selection visit) or lactating women or intending to become pregnant within 6 months ahead,
  • Women of child bearing potential without efficient contraception,
  • Under nutritional supplement or drugs acting on weight or satiety according to the investigator or stopped less than 6 months before the study,
  • With a current or planned in the next 6 months specific diet (hypocaloric, vegan, vegetarian…) or stopped less than 6 months before the study,
  • Treated with drugs acting on visceral fat mass \&inflammation : corticosteroids, neuroleptics, alpha et beta blockers, anti-HIV tritherapy, anti-TNF alpha, antidepressant or anticoagulating agents,
  • Treated with antibiotics in the 3 months prior to selection,
  • With significant change in food habits or in physical activity in the 6 months before the V0 visit,
  • With significant changes in lipid abnormality of antihypertensive treatment within 3 months prior to selection,
  • With a personal history of bulimia or significant eating disorders according to the investigator,
  • Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study,
  • Consuming tobacco more than 10 mg of nicotine per day
  • Consuming drugs,
  • Patients who suffer from claustrophobia,
  • Patients who have contraindications to perform an MRI such as pacemakers, intracranial clips incompatible with MRI, heart valves, hearing aid,... and other types of implants incompatible with MRI,
  • Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision,
  • Presenting a psychological or linguistic incapability to sign the informed consent,
  • Impossible to contact in case of emergency.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

France5 sites

  • CEN Experimental

    Dijon, 21000

  • Eurofins Optimed

    Gières, 38610

  • Institut Pasteur de Lille

    Lille, 59019

  • CIC Pitié Salpêtrière

    Paris, 75651

  • Biofortis

    Saint-Herblain, 44800

Other trials in France

Ireland1 site

  • Atlantia Food Clinical Trials

    Cork

Other trials in Ireland

About this study

Official title: A 3-month Randomized Double Blind Placebo-controlled Multicenter Study to Assess the Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome

The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption.

Read the detailed description

It is expected that the food product STABLOR will reduce visceral fat mass in subjects with metabolic syndrome and therefore will improve cardiometabolic risk factors. The aim of the current study is to assess the impact of a 12-week intake of STABLOR, compared to a placebo, on visceral fat in patients with metabolic syndrome. The primary objective of the study is to assess the efficacy of 12-week STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome. The Secondary outcomes include Anthropometric measurements and body composition, metabolic syndrome status, STABLOR® metabolism, Cardiovascular biomarkers, Systemic inflammation, Quality of life and Behavior.

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

    Stablor sachet

  • placeboDietary supplement

    placebo sachet

Study groups in NCT03692806
Study groupRoleWhat they receive
StablorExperimental2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks
Receives: Dietary Supplement: Stablor
placeboPlacebo comparator2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change of visceral fat mass (in cubic millimeter) assessed by Magnetic Resonance Imaging

    Measured: between week 0, week 9, week 12

Secondary outcomes (14)

  1. Change of visceral fat mass in percentage assessed by Magnetic Resonance Imaging

    Measured: between Week 0, Week 9 and Week 12

  2. Changes of total abdominal fat mass in cubic millimeter assessed by Magnetic Resonance Imaging

    Measured: between Week 0, Week 9 and Week 12

  3. Changes of subcutaneous fat mass in cubic millimeter assessed by Magnetic Resonance Imaging

    Measured: between Week 0, Week 9 and Week 12

  4. Changes of total abdominal fat mass in percentage assessed by Magnetic Resonance Imaging

    Measured: between Week 0, Week 9 and Week 12

  5. Changes of subcutaneous fat mass in percentage assessed by Magnetic Resonance Imaging

    Measured: between Week 0, Week 9 and Week 12

  6. Changes of body fat mass measured by Dual-energy X-ray absorptiometry

    Measured: between Week 0 and Week 12

  7. Changes of body lean mass measured by Dual-energy X-ray absorptiometry

    Measured: between Week 0 and Week 12

  8. Changes of trunk fat assessed by Dual-energy X-ray absorptiometry

    calculated trunk fat

    Measured: between Week 0 and Week 12

  9. Changes of anthropometrics measurements : weight

    Weight

    Measured: between Week 0 and Week 12

  10. Changes of anthropometrics measurements : BMI

    BMI

    Measured: between Week 0 and Week 12

  11. Changes of anthropometrics measurements: Waist circumference

    Waist Circumference

    Measured: between Week 0 and Week 12

  12. Changes of anthropometrics measurements: Hip Circumference

    Hip Circumference

    Measured: between Week 0 and Week 12

  13. Changes of anthropometrics measurements: Waist to Hip ratio

    Waist to Hip ratio

    Measured: between Week 0 and Week 12

  14. Changes of anthropometrics measurements: Waist to Height ratio

    Waist to Height ratio

    Measured: between Week 0 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start11 Sep 2018
  3. Primary completion31 Oct 2019
  4. Study completion16 Dec 2020

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03692806
Sponsor's protocol ID
2018-A01402-53
Acronym
OBEMINALE2
Status last verified
Dec 2020
First submitted
10 Sep 2018
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stablor in people with Metabolic Syndrome, run by LNC THERAPEUTICS at 6 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 10 inclusion and 27 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France, Ireland. 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?

Absolute change of visceral fat mass (in cubic millimeter) assessed by Magnetic Resonance Imaging (time frame: between week 0, week 9, 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 NCT03692806.

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 17 Dec 2020.

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