Effects of a Supplement Derived From Palm Oil on Cholesterol Levels and Chinese Red Yeast Rice in the Blood

• Status: Withdrawn
• Trial end date: 2016-02-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of a palm-oil derived tocotrienol (TRF) supplement or Chinese red yeast rice (CRYR) individually and in combination on blood cholesterol, and particularly LDL cholesterol, in individuals who have either elevated or normal cholesterol levels. Tocotrienols are members of the vitamin E family, and are found in barley, oats, rye, coconut oil and rice bran oil, but the richest source of tocotrienols is palm oil. Certain of these tocotrienols have been shown to be effective in lowering LDL (or 'bad') cholesterol, with no adverse effects on the HDL (or 'good') cholesterol.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Dihydromevinolin; L 647318; Lovastatin; Red yeast rice; Tocopherols; Tocotrienols; Vitamin E

Criteria

Inclusion Criteria:

• Able to read and understand English

• Male or female, 35-70 years old (inclusive)

• Total Fasting Plasma Cholesterol of 200 to 240 mg/dl

• Willing to maintain American heart Association (AHA) Step 1 diet for the duration of the study.

• Agree to abstain from consuming large amounts of grapefruit juice for the duration of the study.

Exclusion Criteria:

• Any subject with an National Cholesterol Education Program (NCEP) 10-year cardiovascular (CV) risk > 10% will be excluded.

• Women who are pregnant or nursing, or trying to get pregnant

• Women of childbearing potential (WOCBP) and who do not agree to use a reliable method of birth control during the study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as 12 consecutive months; or women on hormone replacement therapy, amenorrhea, hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level mIU/mL (milli-International unit). Even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential.

• Concomitant administration with strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone)

• Active liver disease or unexplained persistent elevations of serum transaminases

• Any subject taking large amounts of grapefruit juice (at least 7 days before), cyclosporine, gemfibrozil, colchicine, danazol, diltiazem, dronedarone, verapamil, amiodarone, or ranolazine

• Any subject with a history of myopathy/rhabdomyolysis on lipid-lowering therapy

• Any subject who is taking vitamin E supplements or taking any antibiotics or other medication or dietary supplement which could interfere with the action of tocotrienols

• Any subject who is taking cholesterol lowering medications

• Any subject who has lost >5% of their body weight during the past 3 months.

• Any subject with a history of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatitis or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as BP >160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication and patients wo are clinically euthyroid) as indicated by medical history or routine physical examination.

• Major surgery within 12 weeks prior to subject randomization and/or screening, especially cardiac surgery

• Is currently a smoker who has a therapeutic plan to quit smoking anytime during the study period; or if not a current smoker, has quit smoking within the past 3 months.

• Known HIV positive.

• Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.

• Currently receiving systemic chemotherapy and/or radiotherapy.

• Active bleeding.

• Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

• In the opinion of the study investigator has a risk of non-compliance with study procedures, or cannot read, understand or complete study related materials.