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

NCT02142569 | Withdrawn Phase 2

• 1 other identifier: TOCO-CRYR-118824
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholesterol Lowering

Keywords

Monacolin K; Cholesterol; Tocotrienol-enriched fraction of palm oil (TRF); Chinese Red Yeast Rice (CRYR

Outcome Measures

Primary Outcomes (1)

• Effects of TRF vs. CRYR

  After 2 weeks of run-in individuals with cholesterol levels within the l range of 200 to 240 mg/dl where drug treatment is optional and after acclimation to a step 1 American Heart Association (AHA) diet, 80 subjects will be randomized to one of four groups to receive 1) Placebo; 2) CRYR alone; 3) TRF alone; or 4) CRYR and TRF in combination for 12 weeks. Fasting lipids including cholesterol, triglyceride, and HDL cholesterol will be measured at baseline, 6 weeks and 12 weeks.

  12 weeks

Study Arms (4)

Chinese Red Yeast Rice (CRYR)

ACTIVE COMPARATOR

20 subjects with cholesterol level (200 to 240 mg/dl), ages 35-70 years of age who meet all the eligibility criteria in the screening phase of the study will be assigned to the CRYR arm of the study to evaluate the cholesterol-suppressive actions of CRYR and Tocotrienol-enriched Fraction of Palm Oil (TRF). Subjects will be asked to take 2 CRYR and 2 Sugar Pill/Placebo capsules for 12 weeks.

Drug: Sugar Pill; Drug: Chinese Red Yeast Rice (CRYR)

Tocotrienol-enriched Fraction of Palm Oil (TRF)

ACTIVE COMPARATOR

20 subjects with cholesterol level (200 to 240 mg/dl), ages 35-70 years of age who meet all the eligibility criteria in the screening phase of the study will be assigned to the TRF arm of the study to evaluate the cholesterol-suppressive actions of CRYR and Tocotrienol-enriched Fraction of Palm Oil (TRF). Subjects will be asked to take 2 TRF and 2 Sugar Pill/Placebo capsules for 12 weeks.

Drug: Sugar Pill; Device: Tocotrienol-enriched Fraction of Palm Oil (TRF)

CRYR + TRF

ACTIVE COMPARATOR

20 subjects with cholesterol level (200 to 240 mg/dl), ages 35-70 years of age who meet all the eligibility criteria in the screening phase of the study will be assigned to the TRF + CRYR arm of the study to evaluate the cholesterol-suppressive actions of CRYR and Tocotrienol-enriched Fraction of Palm Oil (TRF). Subjects will be asked to take 2 CRYR and 2 TRF capsules for 12 weeks.

Drug: CRYR + TRF

Sugar Pill

PLACEBO COMPARATOR

20 subjects with cholesterol level (200 to 240 mg/dl), ages 35-70 years of age who meet all the eligibility criteria in the screening phase of the study will be assigned to the placebo (sugar pill) arm of the study to evaluate the cholesterol-suppressive actions of CRYR and Tocotrienol-enriched Fraction of Palm Oil (TRF). Subjects will be asked to take 4 placebo tablets for 12 weeks. Additionally during a two-week run-in period, subjects will be asked to follow the American Heart Association Step 1 dietary regimen and to take a placebo capsule daily to determine their ability to comply with the diet and a pill regimen.

Drug: Sugar Pill

Interventions

Sugar Pill DRUG

Sugar Pills/Placebo 4 capsules/day for 12 weeks.

Also known as: Placebo

Chinese Red Yeast Rice (CRYR); Sugar Pill; Tocotrienol-enriched Fraction of Palm Oil (TRF)

Chinese Red Yeast Rice (CRYR) DRUG

CRYR 1200mg/day, including 6 mg mevinolin as Monacolin K (2 capsules) + placebo (2 capsules) for 12 weeks.

Also known as: Hypocol

Chinese Red Yeast Rice (CRYR)

CRYR + TRF DRUG

CRYR 1200mg/day, including 6 mg mevinolin as Monacolin K (2 capsules) + TRF 300mg/day including 60 mg tocotrienols (2 capsules) per day for 12 weeks.

Also known as: Hypocol, Tocotrienol

CRYR + TRF

Tocotrienol-enriched Fraction of Palm Oil (TRF) DEVICE

TRF 300mg/day, including 60 mg tocotrienols (2 capsules) + placebo (2 capsules) per day for 12 weeks.

Also known as: Tocotrienol

Tocotrienol-enriched Fraction of Palm Oil (TRF)

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Sugars; red yeast rice; Tocotrienols

Intervention Hierarchy (Ancestors)

Carbohydrates; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhaopoing Li, MD, PhD

  UCLA Center for Human Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chief, UCLA Center for Human Nutrition

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 20, 2014
• Study Start: October 30, 2013
• Primary Completion: February 9, 2016
• Study Completion: February 9, 2016
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)