- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692806
Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome (OBEMINALE2)
December 16, 2020 updated by: LNC THERAPEUTICS
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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,
- 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,
Exclusion Criteria:
- 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,
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stablor
2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks
|
Stablor sachet
|
Placebo Comparator: placebo
2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks
|
placebo sachet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute change of visceral fat mass (in cubic millimeter) assessed by Magnetic Resonance Imaging
Time Frame: between week 0, week 9, week 12
|
between week 0, week 9, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of visceral fat mass in percentage assessed by Magnetic Resonance Imaging
Time Frame: between Week 0, Week 9 and Week 12
|
between Week 0, Week 9 and Week 12
|
|
Changes of total abdominal fat mass in cubic millimeter assessed by Magnetic Resonance Imaging
Time Frame: between Week 0, Week 9 and Week 12
|
between Week 0, Week 9 and Week 12
|
|
Changes of subcutaneous fat mass in cubic millimeter assessed by Magnetic Resonance Imaging
Time Frame: between Week 0, Week 9 and Week 12
|
between Week 0, Week 9 and Week 12
|
|
Changes of total abdominal fat mass in percentage assessed by Magnetic Resonance Imaging
Time Frame: between Week 0, Week 9 and Week 12
|
between Week 0, Week 9 and Week 12
|
|
Changes of subcutaneous fat mass in percentage assessed by Magnetic Resonance Imaging
Time Frame: between Week 0, Week 9 and Week 12
|
between Week 0, Week 9 and Week 12
|
|
Changes of body fat mass measured by Dual-energy X-ray absorptiometry
Time Frame: between Week 0 and Week 12
|
between Week 0 and Week 12
|
|
Changes of body lean mass measured by Dual-energy X-ray absorptiometry
Time Frame: between Week 0 and Week 12
|
between Week 0 and Week 12
|
|
Changes of trunk fat assessed by Dual-energy X-ray absorptiometry
Time Frame: between Week 0 and Week 12
|
calculated trunk fat
|
between Week 0 and Week 12
|
Changes of anthropometrics measurements : weight
Time Frame: between Week 0 and Week 12
|
Weight
|
between Week 0 and Week 12
|
Changes of anthropometrics measurements : BMI
Time Frame: between Week 0 and Week 12
|
BMI
|
between Week 0 and Week 12
|
Changes of anthropometrics measurements: Waist circumference
Time Frame: between Week 0 and Week 12
|
Waist Circumference
|
between Week 0 and Week 12
|
Changes of anthropometrics measurements: Hip Circumference
Time Frame: between Week 0 and Week 12
|
Hip Circumference
|
between Week 0 and Week 12
|
Changes of anthropometrics measurements: Waist to Hip ratio
Time Frame: between Week 0 and Week 12
|
Waist to Hip ratio
|
between Week 0 and Week 12
|
Changes of anthropometrics measurements: Waist to Height ratio
Time Frame: between Week 0 and Week 12
|
Waist to Height ratio
|
between Week 0 and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie Déciron, MD, Biofortis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 11, 2018
Primary Completion (Actual)
October 31, 2019
Study Completion (Actual)
December 16, 2020
Study Registration Dates
First Submitted
September 10, 2018
First Submitted That Met QC Criteria
September 24, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A01402-53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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