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EFFECTS OF CARDICHOL, AN HERBAL DIETARY SUPPLEMENT, IN MODERATE HYPERCHOLESTEROLEMIA (CARDICHOL 1)

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ClinicalTrials.gov Identifier: NCT02657759
Recruitment Status : Unknown
Verified January 2016 by Direct Plantes.
Recruitment status was:  Recruiting
First Posted : January 18, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Direct Plantes

Brief 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.

Condition or disease Intervention/treatment Phase
HYPERCHOLESTEROLEMIA Dietary Supplement: CARDICHOL Dietary Supplement: PLACEBO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: EFFECTS OF CARDICHOL, AN HERBAL DIETARY SUPPLEMENT, IN MODERATE HYPERCHOLESTEROLEMIA
Study Start Date : December 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CARDICHOL
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.
Dietary Supplement: CARDICHOL
Placebo Comparator: Placebo

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.

Dietary Supplement: PLACEBO



Primary Outcome Measures :
  1. Change of the fasting blood LDL cholesterol NCEP concentration [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods) [ Time Frame: 4 weeks ]
  2. Change of the fasting blood LDL cholesterol concentration (Friedewald estimation method) [ Time Frame: 8 weeks ]
  3. Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods) [ Time Frame: 12 weeks ]
  4. Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods) [ Time Frame: 4 weeks ]
  5. Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods) [ Time Frame: 8 weeks ]
  6. Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods) [ Time Frame: 12 weeks ]
  7. Change of the fasting blood total cholesterol concentration [ Time Frame: 4 weeks ]
  8. Change of the fasting blood total cholesterol concentration [ Time Frame: 8 weeks ]
  9. Change of the fasting blood total cholesterol concentration [ Time Frame: 12 weeks ]
  10. Change of the fasting blood triglycerides concentration [ Time Frame: 4 weeks ]
  11. Change of the fasting blood triglycerides concentration [ Time Frame: 8 weeks ]
  12. Change of the fasting blood tiglycerides concentration [ Time Frame: 12 weeks ]
  13. Change of the fasting blood apolipoprotein B100 concentration [ Time Frame: 4 weeks ]
  14. Change of the fasting blood apolipoprotein B100 concentration [ Time Frame: 8 weeks ]
  15. Change of the fasting blood apolipoprotein B100 concentration [ Time Frame: 12 weeks ]
  16. Change of the fasting blood glucose concentration [ Time Frame: 4 weeks ]
  17. Change of the fasting blood glucose concentration [ Time Frame: 8 weeks ]
  18. Change of the fasting blood glucose concentration [ Time Frame: 12 weeks ]
  19. Change of the fasting blood hsCRP concentration [ Time Frame: 4 weeks ]
  20. Change of the fasting blood hsCRP concentration [ Time Frame: 8 weeks ]
  21. Change of the fasting blood hsCRP concentration [ Time Frame: 12 weeks ]
  22. Change of the ratio of fasting blood concentrations LDLox/LDLc (NCEP method) [ Time Frame: 8 weeks ]
  23. Change of the fasting arylesterase activity (PON-1) in blood [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. Complete blood count [ Time Frame: 12 weeks ]
  2. Blood Aspartate Amino Transferase [ Time Frame: 12 weeks ]
  3. Blood Alanine Amino Transferase [ Time Frame: 12 weeks ]
  4. Blood Gamma Glutamyl Transpeptidase [ Time Frame: 12 weeks ]
  5. Blood total bilirubin [ Time Frame: 12 weeks ]
  6. Blood creatinine [ Time Frame: 12 weeks ]
  7. Blood urea [ Time Frame: 12 weeks ]
  8. Blood Lactate Deshydrogenase [ Time Frame: 12 weeks ]
  9. Blood Creatine Kinase [ Time Frame: 12 weeks ]
  10. Glycated hemoglobin [ Time Frame: 12 weeks ]
  11. Heart rate [ Time Frame: 12 weeks ]
  12. Systolic Blood Pressure [ Time Frame: 12 weeks ]
  13. Diastolic Blood Pressure [ Time Frame: 12 weeks ]
  14. Body weight [ Time Frame: 4 weeks ]
  15. Body weight [ Time Frame: 8 weeks ]
  16. Body weight [ Time Frame: 12 weeks ]
  17. Physical Activity Score [ Time Frame: 4 weeks ]
  18. Physical Activity Score [ Time Frame: 8 weeks ]
  19. Physical Activity Score [ Time Frame: 12 weeks ]
  20. Total energy intake [ Time Frame: 8 weeks ]
  21. Percentage of energy intake from fat [ Time Frame: 8 weeks ]
  22. Dietary fiber intake [ Time Frame: 8 weeks ]
  23. Saturated Fatty Acids intake [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.
  • 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.

Exclusion Criteria:

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.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657759


Contacts
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Contact: Patrice CHAUVEAU + 33 (0)2 40 20 45 65 patrice.chauveau@mxns.com

Locations
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France
Biofortis Recruiting
Saint-Herblain, France, 44800
Contact: Patrice CHAUVEAU    + 33 (0)2 40 20 45 65    patrice.chauveau@mxns.com   
Principal Investigator: David GENDRE, M.D.         
Sponsors and Collaborators
Direct Plantes
Investigators
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Study Director: Patrice CHAUVEAU BioFortis

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Responsible Party: Direct Plantes
ClinicalTrials.gov Identifier: NCT02657759     History of Changes
Other Study ID Numbers: DPlantes
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases