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

January 19, 2016 updated by: Direct Plantes
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 Overview

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Saint-Herblain, France, 44800
        • Recruiting
        • Biofortis
        • Contact:
        • Principal Investigator:
          • David GENDRE, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the fasting blood LDL cholesterol NCEP concentration
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods)
Time Frame: 4 weeks
4 weeks
Change of the fasting blood LDL cholesterol concentration (Friedewald estimation method)
Time Frame: 8 weeks
8 weeks
Change of the fasting blood LDL cholesterol concentration (NCEP and Friedewald estimation methods)
Time Frame: 12 weeks
12 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Time Frame: 4 weeks
4 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Time Frame: 8 weeks
8 weeks
Change of the fasting blood HDL cholesterol concentration (NCEP and direct methods)
Time Frame: 12 weeks
12 weeks
Change of the fasting blood total cholesterol concentration
Time Frame: 4 weeks
4 weeks
Change of the fasting blood total cholesterol concentration
Time Frame: 8 weeks
8 weeks
Change of the fasting blood total cholesterol concentration
Time Frame: 12 weeks
12 weeks
Change of the fasting blood triglycerides concentration
Time Frame: 4 weeks
4 weeks
Change of the fasting blood triglycerides concentration
Time Frame: 8 weeks
8 weeks
Change of the fasting blood tiglycerides concentration
Time Frame: 12 weeks
12 weeks
Change of the fasting blood apolipoprotein B100 concentration
Time Frame: 4 weeks
4 weeks
Change of the fasting blood apolipoprotein B100 concentration
Time Frame: 8 weeks
8 weeks
Change of the fasting blood apolipoprotein B100 concentration
Time Frame: 12 weeks
12 weeks
Change of the fasting blood glucose concentration
Time Frame: 4 weeks
4 weeks
Change of the fasting blood glucose concentration
Time Frame: 8 weeks
8 weeks
Change of the fasting blood glucose concentration
Time Frame: 12 weeks
12 weeks
Change of the fasting blood hsCRP concentration
Time Frame: 4 weeks
4 weeks
Change of the fasting blood hsCRP concentration
Time Frame: 8 weeks
8 weeks
Change of the fasting blood hsCRP concentration
Time Frame: 12 weeks
12 weeks
Change of the ratio of fasting blood concentrations LDLox/LDLc (NCEP method)
Time Frame: 8 weeks
8 weeks
Change of the fasting arylesterase activity (PON-1) in blood
Time Frame: 8 weeks
8 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Systolic Blood Pressure
Time Frame: 12 weeks
12 weeks
Diastolic Blood Pressure
Time Frame: 12 weeks
12 weeks
Body weight
Time Frame: 12 weeks
12 weeks
Body weight
Time Frame: 8 weeks
8 weeks
Complete blood count
Time Frame: 12 weeks
12 weeks
Blood Alanine Amino Transferase
Time Frame: 12 weeks
12 weeks
Blood Aspartate Amino Transferase
Time Frame: 12 weeks
12 weeks
Blood Gamma Glutamyl Transpeptidase
Time Frame: 12 weeks
12 weeks
Blood total bilirubin
Time Frame: 12 weeks
12 weeks
Blood urea
Time Frame: 12 weeks
12 weeks
Blood creatinine
Time Frame: 12 weeks
12 weeks
Heart rate
Time Frame: 12 weeks
12 weeks
Body weight
Time Frame: 4 weeks
4 weeks
Physical Activity Score
Time Frame: 12 weeks
12 weeks
Blood Lactate Deshydrogenase
Time Frame: 12 weeks
12 weeks
Blood Creatine Kinase
Time Frame: 12 weeks
12 weeks
Glycated hemoglobin
Time Frame: 12 weeks
12 weeks
Physical Activity Score
Time Frame: 4 weeks
4 weeks
Physical Activity Score
Time Frame: 8 weeks
8 weeks
Total energy intake
Time Frame: 8 weeks
8 weeks
Percentage of energy intake from fat
Time Frame: 8 weeks
8 weeks
Dietary fiber intake
Time Frame: 8 weeks
8 weeks
Saturated Fatty Acids intake
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Patrice CHAUVEAU, Biofortis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DPlantes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HYPERCHOLESTEROLEMIA

3
Subscribe