Moderate HypercholesterolemiaNCT02198703
A Trial to Evaluate the Efficacy of AB-Life Probiotic Product on LDL-Cholesterol Reduction in Moderate Hypercholesterolemia
A study testing Probiotics bacterial strains in people with Moderate Hypercholesterolemia, run by AB Biotics, SA at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Hypercholesterolemia
- What is being tested?
- Probiotics bacterial strains
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2014to Jul 2015
- 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
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator.
- Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 standard drinks daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study.
- Smoking more than 10 cigarettes daily or not agreeing to keep his smoking habits unchanged throughout the study.
- Recent history of chronic alcohol or drug abuse (in the last 2 years).
- Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity (defined as more than 10 hours of significant physical activity a week, walking excluded).
- Who made a blood donation in the 3 months before the randomization or intending to make it within 4 months ahead.
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
- Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros.
- 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.
- After V1 biological analysis the subjects will be considered as non eligible to the study on the following criteria :
- Fasting plasma glucose level > 1,26 g/L (6,99 mmol/L).
- Fasting plasma triglycerides > 3,5 g/L (3,95 mmol/L).
- Fasting plasma TC, HDLc or insulin with an abnormality judged as clinically significant according to the investigator.
- After V2 biological analysis the subjects will be considered as non eligible to the study on the following criteria:
- Fasting plasma TC, HDL or TG with an abnormality judged as clinically significant according to the investigator.
- Serum AST, ALT, GGT, ALP or bilirubin with an abnormality judged as clinically significant according to the investigator.
- Serum urea or creatinine with an abnormality judged as clinically significant according to the investigator.
- Complete blood count with clinically significant abnormality according to the investigator.
- Volunteers with the following criteria at the V3 will be considered as non eligible to the study:
- Capsules' consumption less than 80% of capsules during the run-in period (since V1) according to the quantities returned.
- Gastroenteritis history finished less than 2 weeks before the randomization.
- The included subjects who cannot be randomized at V3 because of a too short wash out period related to the non inclusion criteria E8, E10, E12 or E34 can delay their visit V3 without to exceed 28 days from the visit V2.
- 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 (except for E33 criteria).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL FOR EVALUATING THE EFFICACY OF AB-LIFE PROBIOTIC PRODUCT ON THE LDL-CHOLESTEROL REDUCTION IN THE MODERATE HYPERCHOLESTEROLEMIA
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
- Being tested
- Probiotics bacterial strains, Placebo
- Keywords
- Probiotics, AB-Life, LDL-cholesterol, Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics bacterial strainsDietary supplement
Also called AB-Life
PlaceboDietary supplement
Also called AB-life
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotics bacterial strains |
| Placebo | Placebo comparator | 1 capsule of placebo daily during 12 weeks consumed immediately before, after or during the breakfast. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the fasting blood LDL cholesterol concentration
Measured: 12 weeks
Secondary outcomes (46)
Change in fasting blood total cholesterol concentration
Measured: 4 weeks
Change in fasting blood total cholesterol concentration
Measured: 12 weeks
Change in fasting blood LDLc concentration
Measured: 4 weeks
Change in fasting blood HDLc concentration
Measured: 4 weeks
Change in fasting blood HDLc concentration
Measured: 12 weeks
Change in fasting blood ratio total cholesterol / HDLc concentrations
Measured: 4 weeks
Change in fasting blood ratio total cholesterol / HDLc concentrations
Measured: 12 weeks
Change in fasting blood ratio LDLc / HDLc concentrations
Measured: 4 weeks
Change in fasting blood ratio LDLc / HDLc concentrations
Measured: 12 weeks
Change in fasting blood triglycerides concentration
Measured: 4 weeks
Change in fasting blood triglycerides concentration
Measured: 12 weeks
Change in fasting blood Apo A1 concentration
Measured: 4 weeks
Change in fasting blood Apo A1 concentration
Measured: 12 weeks
Change in fasting blood Apo B100 concentration
Measured: 4 weeks
Change in fasting blood Apo B100 concentration
Measured: 12 weeks
Change in fasting blood insulin concentration
Measured: 4 weeks
Change in fasting blood insulin concentration
Measured: 12 weeks
Change in fasting blood glucose concentration
Measured: 12 weeks
Change in fasting blood glucose concentration
Measured: 4 weeks
Change in fasting blood acetate concentration
Measured: 12 weeks
Change in fasting blood propionate concentration
Measured: 12 weeks
Change in fasting blood acetate / propionate concentrations
Measured: 12 weeks
Change in SCORE - European Low Risk Chart of fatal cardiovascular disease
Measured: 4 weeks
Change in SCORE - European Low Risk Chart of fatal cardiovascular disease
Measured: 12 weeks
Change in fasting blood hsCRP concentration
Measured: 12 weeks
Complete blood count
Measured: 12 weeks
Blood Alkaline Phosphatase
Measured: 12 weeks
Blood Alanine Amino Transferase
Measured: 12 weeks
Blood Aspartate Amino Transferase
Measured: 12 weeks
Blood Gamma Glutamyl Transpeptidase
Measured: 12 weeks
Blood total bilirubin
Measured: 12 weeks
Blood urea
Measured: 12 weeks
Blood creatinine
Measured: 12 weeks
Heart rate
Measured: 4 weeks
Heart rate
Measured: 12 weeks
Systolic Blood Pressure
Measured: 4 weeks
Diastolic Blood Pressure
Measured: 4 weeks
Diastolic Blood Pressure
Measured: 12 weeks
Systolic Blood Pressure
Measured: 12 weeks
Body weight
Measured: 4 weeks
Body weight
Measured: 12 weeks
Physical Activity Score
Measured: 12 weeks
Total energy intake
Measured: 12 weeks
Percentage of energy intake from fat
Measured: 12 weeks
Dietary fiber intake
Measured: 12 weeks
Saturated Fatty Acids intake
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Gendre, M.D., Principal investigator, BioFortisAriana Salavert, Ph. D., Study director, AB-Biotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198703
- Sponsor's protocol ID
- AB-Life study #3
- Status last verified
- Sep 2015
- First submitted
- 23 Jul 2014
- Last updated
- 31 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL FOR EVALUATING THE EFFICACY OF AB-LIFE PROBIOTIC PRODUCT ON THE LDL-CHOLESTEROL REDUCTION IN THE MODERATE HYPERCHOLESTEROLEMIA
- ClinicalTrials.gov ID
- NCT02198703
- Acronym / sponsor ID
- AB-Life study #3
- Conditions
- Moderate Hypercholesterolemia
- Keywords
- Probiotics, AB-Life, LDL-cholesterol, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB-Life | Experimental | Dietary Supplement: Probiotics bacterial strains1 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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 capsule of placebo daily during 12 weeks consumed immediately before, after or during the breakfast. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (40 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics bacterial strainsAlso: AB-Life | Dietary supplement | AB-Life |
| PlaceboAlso: AB-life | Dietary supplement | Placebo |
Primary outcome
Change of the fasting blood LDL cholesterol concentration
Time frame: 12 weeks
46 secondary outcomes
Change in fasting blood total cholesterol concentration
Time frame: 4 weeks
Change in fasting blood total cholesterol concentration
Time frame: 12 weeks
Change in fasting blood LDLc concentration
Time frame: 4 weeks
Change in fasting blood HDLc concentration
Time frame: 4 weeks
Change in fasting blood HDLc concentration
Time frame: 12 weeks
Change in fasting blood ratio total cholesterol / HDLc concentrations
Time frame: 4 weeks
Change in fasting blood ratio total cholesterol / HDLc concentrations
Time frame: 12 weeks
Change in fasting blood ratio LDLc / HDLc concentrations
Time frame: 4 weeks
Change in fasting blood ratio LDLc / HDLc concentrations
Time frame: 12 weeks
Change in fasting blood triglycerides concentration
Time frame: 4 weeks
Change in fasting blood triglycerides concentration
Time frame: 12 weeks
Change in fasting blood Apo A1 concentration
Time frame: 4 weeks
Change in fasting blood Apo A1 concentration
Time frame: 12 weeks
Change in fasting blood Apo B100 concentration
Time frame: 4 weeks
Change in fasting blood Apo B100 concentration
Time frame: 12 weeks
Change in fasting blood insulin concentration
Time frame: 4 weeks
Change in fasting blood insulin concentration
Time frame: 12 weeks
Change in fasting blood glucose concentration
Time frame: 12 weeks
Change in fasting blood glucose concentration
Time frame: 4 weeks
Change in fasting blood acetate concentration
Time frame: 12 weeks
Change in fasting blood propionate concentration
Time frame: 12 weeks
Change in fasting blood acetate / propionate concentrations
Time frame: 12 weeks
Change in SCORE - European Low Risk Chart of fatal cardiovascular disease
Time frame: 4 weeks
Change in SCORE - European Low Risk Chart of fatal cardiovascular disease
Time frame: 12 weeks
Change in fasting blood hsCRP concentration
Time frame: 12 weeks
Complete blood count
Time frame: 12 weeks
Blood Alkaline Phosphatase
Time frame: 12 weeks
Blood Alanine Amino Transferase
Time frame: 12 weeks
Blood Aspartate Amino Transferase
Time frame: 12 weeks
Blood Gamma Glutamyl Transpeptidase
Time frame: 12 weeks
Blood total bilirubin
Time frame: 12 weeks
Blood urea
Time frame: 12 weeks
Blood creatinine
Time frame: 12 weeks
Heart rate
Time frame: 4 weeks
Heart rate
Time frame: 12 weeks
Systolic Blood Pressure
Time frame: 4 weeks
Diastolic Blood Pressure
Time frame: 4 weeks
Diastolic Blood Pressure
Time frame: 12 weeks
Systolic Blood Pressure
Time frame: 12 weeks
Body weight
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gendre, M.D. principal investigator
BioFortis
Ariana Salavert, Ph. D. study director
AB-Biotics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics bacterial strains in people with Moderate Hypercholesterolemia, run by AB Biotics, SA at 2 sites in France.
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 13 inclusion and 40 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 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Change of the fasting blood LDL cholesterol concentration (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.