Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02634606
Status:
TERMINATED
Last Update Posted:
2019-02-12
First Post:
2014-09-26
Brief Title:
Effects of a Supplement Derived From Palm Oil on Cholesterol Levels 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 on Serum Lipids in Hypercholesterolemic Subjects
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to obtain supplement for this study Unable to recruit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRF
Brief Summary:
Elevated blood cholesterol and particularly LDL cholesterol is a risk factor for heart disease Tocotrienols are naturally-occurring compounds in foods that may have beneficial effects on blood cholesterol 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 The purpose of this study is to determine the effects of a palm-oil derived tocotrienol supplement on blood cholesterol and particularly LDL cholesterol in individuals who are taking statins and have either elevated or normal cholesterol levels Study subjects will consume a palm-oil derived supplement of tocotrienol for 3 months to determine its effects on LDL cholesterol
Detailed Description:
Both tocotrienols and tocopherols whose derivatives are in eight different isoforms are closely related structurally Tocopherols are generally present in common vegetable oils ie soy canola However tocotrienols are concentrated in cereal grains ie oat barley and rye rice bran with the highest level found in crude palm oil The development of new cholesterol-lowering agents has been given more and more attention by pharmaceutical companies due to the strong relationship between cholesterol and atherosclerosis Tocotrienols especially δ- and γ-tocotrienols were shown to be effective nutritional agents to treat high cholesterol in recent research programs In particular γ-tocotrienol appears to inhibit 3-hydroxy-3-methylglutaryl-coenzyme A reductase at a posttranscriptional level and there is some evidence that tocopherols antagonize this effect Therefore the current study is designed to demonstrate that treatment with a tocotrienol-enriched fraction of palm oil for a three month period will lead to a significant reduction in LDL cholesterol with no effect on HDL cholesterol in patients whose cholesterol level is not adequately controlled in spite of statins This objective will be achieved utilizing a simple three arm randomized placebo-controlled trial in a total of 99 subjects After acclimation to a step I AHA diet and no supplemental vitamin E in the diet subjects will be given either a placebo capsule or a tocotrienol 120mg or 240mg capsule in addition to their statin medications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None