HYPERCHOLESTEROLEMIACARDICHOL 1NCT02657759
EFFECTS OF CARDICHOL, AN HERBAL DIETARY SUPPLEMENT, IN MODERATE HYPERCHOLESTEROLEMIA
A study testing CARDICHOL in people with HYPERCHOLESTEROLEMIA, run by Direct Plantes at 1 site in France.
Trial summary
This research aims to evaluate the effect of CARDICHOL chronic consumption (12 weeks) on lipid metabolism and especially on blood LDL cholesterol 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
- HYPERCHOLESTEROLEMIA
- What is being tested?
- CARDICHOL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to May 2016
- 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 V0 with a checking at V1):
- Age between 18 and 65 years (limits included).
- BMI between 18,5 and 30 kg/m² (limits excluded).
- For women: Non menopausal with the same reliable contraception since at least three cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom alone without spermicide gel excluded) or menopausal without or with hormone replacement therapy (oestrogenic replacement therapy begun from less than 3 month excluded).
- 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 V0 biological analysis the subjects will be eligible to the study on the following criteria:
- Fasting blood LDLc level (Friedewald estimation method) between 1,3 and 2,2g/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 V0 with a checking at V1):
- Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder.
- 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.
- Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient.
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- Pregnant or lactating women or intending to become pregnant within 4 months ahead.
- Requiring a cholesterol lowering by immediate pharmacologic intervention according to the current recommendations (AFSSAPS 2005).
- 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 "health foods" which are known to decrease LDLc or triglycerides (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, etc.) or stopped less than 3 months 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 4 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 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.
- 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 5 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 V0 biological analysis the subjects will be considered as non eligible to the study on the following criteria:
- Fasting blood glucose level > 1,26 g/L (6,99 mmol/L).
- Fasting blood triglycerides > 3,5 g/L (3,95 mmol/L).
- Fasting blood TC > 4,5 g/L or HDLc < 0,1 g/L with an abnormality judged as clinically significant according to the investigator.
- Blood AST > 1,68 µkat/L, ALT > 1,70 µkat/L or GGT > 2,55 µkat/L (values corresponding to 2,5xULN).
- Blood urea > 12,11 mmol/L (value corresponding to 1,5xULN) or creatinine > 125 µmol/L.
- Complete blood count with hemoglobin < 11 g/L or leucocytes < 3000 / mm3 or leucocytes > 16000 /mm3 or clinically significant abnormality according to the investigator.
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Biofortis
Saint-Herblain, 44800
Patrice CHAUVEAU, + 33 (0)2 40 20 45 65, patrice.chauveau@mxns.com
David GENDRE, M.D.
About this study
This research aims to evaluate the effect of CARDICHOL chronic consumption (12 weeks) on lipid metabolism and especially on blood LDL cholesterol in volunteers with moderate hypercholesterolemia.
- Conditions
- HYPERCHOLESTEROLEMIA
- Being tested
- CARDICHOL, PLACEBO
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDICHOLDietary supplement
PLACEBODietary supplement
| Study group | Role | What they receive |
|---|---|---|
| CARDICHOL | Experimental | Food supplement formula in shape of pill called CARDICHOL. 2 pills daily during 12 weeks (from visit V1 to visit V4). One pill immediately before, after or during breakfast and lunch. Receives: Dietary Supplement: CARDICHOL |
| Placebo | Placebo comparator | placebo with the same characteristics, appearance, packaging, and composition as the active formula, except for active ingredients replaced by dicalcium phosphate and flavouring substances.
2 pills daily during 12 weeks (from visit V1 to visit V4). One pill immediately before, after or during breakfast and lunch. 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 NCEP concentration
Measured: 8 weeks
Secondary outcomes (23)
Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods)
Measured: 4 weeks
Change of the fasting blood LDL cholesterol concentration (Friedewald estimation method)
Measured: 8 weeks
Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods)
Measured: 12 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Measured: 4 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Measured: 8 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Measured: 12 weeks
Change of the fasting blood total cholesterol concentration
Measured: 4 weeks
Change of the fasting blood total cholesterol concentration
Measured: 8 weeks
Change of the fasting blood total cholesterol concentration
Measured: 12 weeks
Change of the fasting blood triglycerides concentration
Measured: 4 weeks
Change of the fasting blood triglycerides concentration
Measured: 8 weeks
Change of the fasting blood tiglycerides concentration
Measured: 12 weeks
Change of the fasting blood apolipoprotein B100 concentration
Measured: 4 weeks
Change of the fasting blood apolipoprotein B100 concentration
Measured: 8 weeks
Change of the fasting blood apolipoprotein B100 concentration
Measured: 12 weeks
Change of the fasting blood glucose concentration
Measured: 4 weeks
Change of the fasting blood glucose concentration
Measured: 8 weeks
Change of the fasting blood glucose concentration
Measured: 12 weeks
Change of the fasting blood hsCRP concentration
Measured: 4 weeks
Change of the fasting blood hsCRP concentration
Measured: 8 weeks
Change of the fasting blood hsCRP concentration
Measured: 12 weeks
Change of the ratio of fasting blood concentrations LDLox/LDLc (NCEP method)
Measured: 8 weeks
Change of the fasting arylesterase activity (PON-1) in blood
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direct Plantes
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice CHAUVEAU, Study director, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657759
- Sponsor's protocol ID
- DPlantes
- Acronym
- CARDICHOL 1
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF CARDICHOL, AN HERBAL DIETARY SUPPLEMENT, IN MODERATE HYPERCHOLESTEROLEMIA
- ClinicalTrials.gov ID
- NCT02657759
- Acronym / sponsor ID
- CARDICHOL 1 / DPlantes
- Conditions
- HYPERCHOLESTEROLEMIA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Direct PlantesIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 18 Jan 2016 (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 research aims to evaluate the effect of CARDICHOL chronic consumption (12 weeks) on lipid metabolism and especially on blood LDL cholesterol in volunteers with moderate hypercholesterolemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARDICHOL | Experimental | Dietary Supplement: CARDICHOLFood supplement formula in shape of pill called CARDICHOL. 2 pills daily during 12 weeks (from visit V1 to visit V4). One pill immediately before, after or during breakfast and lunch. |
| Placebo | Placebo comparator | Dietary Supplement: PLACEBOplacebo with the same characteristics, appearance, packaging, and composition as the active formula, except for active ingredients replaced by dicalcium phosphate and flavouring substances. 2 pills daily during 12 weeks (from visit V1 to visit V4). One pill immediately before, after or during breakfast and lunch. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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 V0 with a checking at V1):
- Age between 18 and 65 years (limits included).
- BMI between 18,5 and 30 kg/m² (limits excluded).
- For women: Non menopausal with the same reliable contraception since at least three cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom alone without spermicide gel excluded) or menopausal without or with hormone replacement therapy (oestrogenic replacement therapy begun from less than 3 month excluded).
- 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 (32 listed)
- Volunteers with the following criteria will be considered as non eligible to the study (assessment based on the medical examination performed at V0 with a checking at V1):
- Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder.
- 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.
- Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
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 |
|---|---|---|
| CARDICHOL | Dietary supplement | CARDICHOL |
| PLACEBO | Dietary supplement | Placebo |
Primary outcome
Change of the fasting blood LDL cholesterol NCEP concentration
Time frame: 8 weeks
23 secondary outcomes
Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods)
Time frame: 4 weeks
Change of the fasting blood LDL cholesterol concentration (Friedewald estimation method)
Time frame: 8 weeks
Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods)
Time frame: 12 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Time frame: 4 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Time frame: 8 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Time frame: 12 weeks
Change of the fasting blood total cholesterol concentration
Time frame: 4 weeks
Change of the fasting blood total cholesterol concentration
Time frame: 8 weeks
Change of the fasting blood total cholesterol concentration
Time frame: 12 weeks
Change of the fasting blood triglycerides concentration
Time frame: 4 weeks
Change of the fasting blood triglycerides concentration
Time frame: 8 weeks
Change of the fasting blood tiglycerides concentration
Time frame: 12 weeks
Change of the fasting blood apolipoprotein B100 concentration
Time frame: 4 weeks
Change of the fasting blood apolipoprotein B100 concentration
Time frame: 8 weeks
Change of the fasting blood apolipoprotein B100 concentration
Time frame: 12 weeks
Change of the fasting blood glucose concentration
Time frame: 4 weeks
Change of the fasting blood glucose concentration
Time frame: 8 weeks
Change of the fasting blood glucose concentration
Time frame: 12 weeks
Change of the fasting blood hsCRP concentration
Time frame: 4 weeks
Change of the fasting blood hsCRP concentration
Time frame: 8 weeks
Change of the fasting blood hsCRP concentration
Time frame: 12 weeks
Change of the ratio of fasting blood concentrations LDLox/LDLc (NCEP method)
Time frame: 8 weeks
Change of the fasting arylesterase activity (PON-1) in blood
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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.
Patrice CHAUVEAU study director
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARDICHOL in people with HYPERCHOLESTEROLEMIA, run by Direct Plantes at 1 site 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 11 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrice CHAUVEAU (+ 33 (0)2 40 20 45 65, patrice.chauveau@mxns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the fasting blood LDL cholesterol NCEP concentration (time frame: 8 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 20 Jan 2016.