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

NCT ID: NCT03692806

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-11
• Study Completion Date: 2020-12-16

Brief 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.

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Stablor

2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks

Group Type: EXPERIMENTAL

Stablor

Intervention Type: DIETARY_SUPPLEMENT

Stablor sachet

placebo

2 sachets to be taken twice a day at breakfast and in the afternoon as a snack during 12 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo sachet

Interventions

Stablor

Stablor sachet

Intervention Type: DIETARY_SUPPLEMENT

placebo

placebo sachet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biofortis Mérieux NutriSciences

OTHER

Sponsor Role: collaborator

StatistiCal BV Wassenarr, The Netherland represented by Dr W.Calame

UNKNOWN

Sponsor Role: collaborator

LNC THERAPEUTICS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Déciron, MD

Role: PRINCIPAL_INVESTIGATOR

BioFortis

Locations

CEN Experimental

Dijon, , France

Eurofins Optimed

Gières, , France

Institut Pasteur de Lille

Lille, , France

CIC Pitié Salpêtrière

Paris, , France

Biofortis

Saint-Herblain, , France

Atlantia Food Clinical Trials

Cork, , Ireland

Countries

France; Ireland

Other Identifiers

2018-A01402-53

Identifier Type: -

Identifier Source: org_study_id