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Trial record 17 of 231 for:    yeast

Effects of a Supplement Derived From Palm Oil on Cholesterol Levels and Chinese Red Yeast Rice in the Blood (TOCO-CRYR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02142569
Recruitment Status : Withdrawn (We were unable to procure the supplement for this study.)
First Posted : May 20, 2014
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE May 14, 2014
First Posted Date  ICMJE May 20, 2014
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE October 30, 2013
Actual Primary Completion Date February 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
Effects of TRF vs. CRYR [ Time Frame: 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02142569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Supplement Derived From Palm Oil on Cholesterol Levels and Chinese Red Yeast Rice in the Blood
Official Title  ICMJE Effects of a Tocotrienol-Enriched Fraction of Palm Oil and Chinese Red Yeast Rice on Serum Lipids in Hypercholesterolemic Subjects
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.
Detailed Description

The current study is designed to determine whether a dietary supplement, the tocotrienol-enriched fraction of palm oil (TRF) will enhance the effects of a botanical supplement, Chinese Red Yeast Rice (CRYR). Originally, CRYR was sold as a dietary supplement in the United States until 2001. Since that time, CRYR containing monacolin K which is chemically identical to mevinolin sold as Mevacor (now off patent) has been classified as an unapproved drug. At the present time, there are many brands of CRYR sold over the counter in drug stores and warehouse chains in the U.S. However, none of these have the amounts of Monacolin K found in the CRYR which was the subject of FDA action in 2001 and none have been proven effective in lowering cholesterol. FDA monitors the levels of monacolin K in over the counter supplements and limits the approved levels to less than 2 mg when effective doses are between 6 and 10 mg, in this study we will use . two capsules per day where each capsule contains 3 mg of mevinolin as Monacolin K. The capsules also contain the rice on which the CRYR is fermented for a total mass of 600 mg per capsule or a total daily dose of 1200mg.

The study was originally designed to focus on the effects of tocotrienol, utilized with a statin drug. However, subjects being recruited with cholesterol levels between 200 mg/dl and 240 mg/dl did not want to take a drug. This made it impossible to recruit subjects. Therefore, the current protocol is being submitted using a CRYR from China which has known effects on serum lipid and will be used in this study to examine whether tocotrienol by suppressing the increase in gene expression of 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA) reductase will further lower serum lipid compared to the CRYR alone.

This objective will be achieved by recruiting individuals with cholesterol levels within the l range of 200 to 240 mg/dl where drug treatment is optional. After acclimation to a step 1 American Heart Association (AHA) diet, 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cholesterol Lowering
Intervention  ICMJE
  • Drug: Sugar Pill
    Sugar Pills/Placebo 4 capsules/day for 12 weeks.
    Other Name: Placebo
  • Drug: Chinese Red Yeast Rice (CRYR)
    CRYR 1200mg/day, including 6 mg mevinolin as Monacolin K (2 capsules) + placebo (2 capsules) for 12 weeks.
    Other Name: Hypocol
  • Drug: CRYR + TRF
    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.
    Other Names:
    • Hypocol
    • Tocotrienol
  • Device: Tocotrienol-enriched Fraction of Palm Oil (TRF)
    TRF 300mg/day, including 60 mg tocotrienols (2 capsules) + placebo (2 capsules) per day for 12 weeks.
    Other Name: Tocotrienol
Study Arms  ICMJE
  • Active Comparator: Chinese Red Yeast Rice (CRYR)
    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.
    Interventions:
    • Drug: Sugar Pill
    • Drug: Chinese Red Yeast Rice (CRYR)
  • Active Comparator: Tocotrienol-enriched Fraction of Palm Oil (TRF)
    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.
    Interventions:
    • Drug: Sugar Pill
    • Device: Tocotrienol-enriched Fraction of Palm Oil (TRF)
  • Active Comparator: CRYR + TRF
    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.
    Intervention: Drug: CRYR + TRF
  • Placebo Comparator: Sugar Pill
    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.
    Intervention: Drug: Sugar Pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2014)
80
Actual Study Completion Date  ICMJE February 9, 2016
Actual Primary Completion Date February 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02142569
Other Study ID Numbers  ICMJE TOCO-CRYR-118824
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhaoping Li, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zhaopoing Li, MD, PhD UCLA Center for Human Nutrition
PRS Account University of California, Los Angeles
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP