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

NCT03692806 | Completed

• 1 other identifier: 2018-A01402-53
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 6

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

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

  between week 0, week 9, week 12

Secondary Outcomes (14)

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

  between Week 0, Week 9 and Week 12

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

  between Week 0, Week 9 and Week 12

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

  between Week 0, Week 9 and Week 12

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

  between Week 0, Week 9 and Week 12

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

  between Week 0, Week 9 and Week 12

Study Arms (2)

Stablor

EXPERIMENTAL

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

Dietary Supplement: Stablor

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

Stablor DIETARY_SUPPLEMENT

Stablor sachet

Stablor

placebo DIETARY_SUPPLEMENT

placebo sachet

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• LNC THERAPEUTICS: lead
• Biofortis Mérieux NutriSciences: collaborator
• StatistiCal BV Wassenarr, The Netherland represented by Dr W.Calame: collaborator

Study Sites (6)

CEN Experimental

Dijon, 21000, France

Location

Eurofins Optimed

Gières, 38610, France

Location

Institut Pasteur de Lille

Lille, 59019, France

Location

CIC Pitié Salpêtrière

Paris, 75651, France

Location

Biofortis

Saint-Herblain, 44800, France

Location

Atlantia Food Clinical Trials

Cork, Ireland

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marie Déciron, MD

  BioFortis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: October 2, 2018
• Study Start: September 11, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 16, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); IE (1)