Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02142569
Status:
WITHDRAWN
Last Update Posted:
2019-01-11
First Post:
2014-05-14
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:
University of California Los Angeles
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WITHDRAWN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 US 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 mgdl and 240 mgdl 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 mgdl 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 mgdl and 240 mgdl 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 mgdl 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:
None
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?:
None