Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 12:51 PM
Study NCT ID:
NCT02142569
Status:
WITHDRAWN
Last Update Posted:
2019-01-11
First Post:
2014-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Supplement Derived From Palm Oil on Cholesterol Levels and Chinese Red Yeast Rice in the Blood
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
Effects of a Tocotrienol-Enriched Fraction of Palm Oil and Chinese Red Yeast Rice on Serum Lipids in Hypercholesterolemic Subjects
Status:
WITHDRAWN
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We were unable to procure the supplement for this study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOCO-CRYR
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: