A Trial to Evaluate the Efficacy of AB-Life Probiotic Product on LDL-Cholesterol Reduction in Moderate Hypercholesterolemia

NCT02198703 | Completed

• 1 other identifier: AB-Life study #3
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.

Conditions

Moderate Hypercholesterolemia

Keywords

Probiotics; AB-Life; LDL-cholesterol; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Change of the fasting blood LDL cholesterol concentration

  12 weeks

Secondary Outcomes (46)

• Change in fasting blood total cholesterol concentration

  4 weeks

• Change in fasting blood total cholesterol concentration

  12 weeks

• Change in fasting blood LDLc concentration

  4 weeks

• Change in fasting blood HDLc concentration

  4 weeks

• Change in fasting blood HDLc concentration

  12 weeks

Other Outcomes (31)

• Fasting blood PCSK9 concentration

  12 weeks

• Fasting blood FGF-19 concentration

  12 weeks

• Fasting blood LDLox concentration

  12 weeks

Study Arms (2)

AB-Life

EXPERIMENTAL

1 capsule of AB-Life daily during 12 weeks consumed immediately before, after or during the breakfast. The daily dose corresponds to the intake of 1.8E+10 CFU. According to the product's stability and the duration of the experiment, all participants receive at least 1.2E+09 CFU/capsule/day by the end of the study.

Dietary Supplement: Probiotics bacterial strains

Placebo

PLACEBO COMPARATOR

1 capsule of placebo daily during 12 weeks consumed immediately before, after or during the breakfast.

Dietary Supplement: Placebo

Interventions

Probiotics bacterial strains DIETARY_SUPPLEMENT

Also known as: AB-Life

AB-Life

Placebo DIETARY_SUPPLEMENT

Also known as: AB-life

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:

• To be eligible to the study, male and female volunteers will have to fulfill the following criteria (assessment based on the medical examination performed at V1 with a checking at V3):
• Age between 18 and 65 years (limits included).
• BMI between 18,5 and 30 kg/m² ((limits excluded).
• For women : Non menopausal with reliable contraception since at least two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom alone without spermicide gel and oestrogenic contraceptive excluded) or menopausal without oestrogenic replacement therapy.
• 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.
• Affiliated with a social security scheme.
• Agree to be registered on the volunteers in biomedical research file.
• After V1 biological analysis the subjects will be eligible to the visit V2 on the following criteria:
• \- Fasting plasma LDLc level (Friedewald estimation method) between 1,3 and 1,89 g/L (3,35 - 4,92 mmol/L, limits included with ± 2% tolerated around).
• After V2 biological analysis the subjects will be eligible to the study on the following criteria:
• \- Fasting plasma LDLc level (Friedewald estimation method) between 1,3 and 1,89 g/L (3,35 - 4,92 mmol/L, limits included with ± 2% tolerated around).
• A re-screening can occur from 2 months after the exit of study for failure to comply with the one or more of the eligibility criteria listed above.

You may not qualify if:

• Volunteers with the following criteria will be considered as non eligible to the study (assessment based on the medical examination performed at V1 with a checking at V3):
• Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other chronic severe disease.
• Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease).
• With a history of ischemic cardiovascular event or, during the previous 6 months a surgical procedure.
• With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient.
• Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).
• Pregnant or lactating women or intending to become pregnant within 5 months ahead.
• Under lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 4 months before the randomization.
• Under medication which could affect blood lipid parameters (e.g. long-term corticosteroid systemic drug, systemic antibodies, androgens or phenytoin, etc.) or stopped less than 1 month before the randomization (stable long-term treatment with beta blocker or thiazide diuretics tolerated).
• Regular intake of dietary supplements or "functional foods" which may interfere with lipid absorption and/or metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, omega-3 fatty acids like fish oils, ST HUBERT OMEGA 3 or PRIMEVERE products, soya protein, oat fiber like QUAKER OATS, psyllium, chitosan, guar gum, inulin, etc.) or stopped less than 3 months before the randomization.
• Under treatment which could disturb microbiota balance or stopped in a too short period before the randomization (e.g. less than one month for laxatives, less than 6 weeks for antibiotics).
• Regular intake of dietary supplements or "functional foods" containing prebiotics, probiotics or symbiotics (e.g. BION 3, LACTIBIANE, ACTIMEL, ACTIVIA, etc.) or stopped less than 1 month before the randomization.
• Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the randomization.
• With significant change in food habits or in physical activity in the 3 months before randomization or not agreeing to keep them unchanged throughout the study.
• With reported body weight variation \> 5% in the 3 months prior the randomization or with a hyper or hypocaloric diet planned in the next 5 months.

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (2)

Naturalpha

Lille, 59020, France

Location

Biofortis

Saint-Herblain, 44800, France

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David Gendre, M.D.

  BioFortis

  PRINCIPAL INVESTIGATOR

• Ariana Salavert, Ph. D.

  AB-BIOTICS

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 24, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 31, 2018

Record last verified: 2015-09

Locations

FR (2)