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Unable to obtain supplement for this study. Unable to recruit.
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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.
Both tocotrienols and tocopherols, whose derivatives are in eight different isoforms, are closely related structurally. Tocopherols are generally present in common vegetable oils (i.e. 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamma Delta Tocotrienols - Low Dose | Active Comparator | 33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (63mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. |
|
| Gamma Delta Tocotrienols - High Dose | Active Comparator | 33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. |
|
| Sugar Pill | Placebo Comparator | 33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma Delta Tocotrienols - Low Dose | Drug | 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL Cholesterol Over Time Between the 3 Groups | Mixed-effects regression models will be used to evaluate the change in LDL cholesterol over time between the 3 groups | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, MD, PhD | University of California, Los Angeles | Principal Investigator |
| David Heber, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187 | Los Angeles | California | 90095 | United States |
Thirteen subjects with cholesterol level (>180 mg/dl), aged 37-64, taking statins drug at the time were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill) for 12 weeks. Randomization was not performed due to limited subjects recruited.
The enrollment period was 3/22/2011 - 11/13/2015 and took place in a private setting the clinic located at the site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Randomization | Thirteen enrolled subjects were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill). Randomization was not performed prior to study termination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled subjects were not assigned to an intervention arm prior to study termination.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Randomization | Thirteen enrolled subjects were to be assigned to the low dose arm (TRF 63 mg), high dose arm (RTF 127 mg) or control (sugar pill). Randomization was not performed prior to study termination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in LDL Cholesterol Over Time Between the 3 Groups | Mixed-effects regression models will be used to evaluate the change in LDL cholesterol over time between the 3 groups | Randomization was not performed prior to study termination | Posted | Baseline and 12 weeks |
|
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Adverse events were not reported/collected because no participants were assigned to an intervention arm prior to study termination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gamma Delta Tocotrienols - Low Dose | 33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (63mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Gamma Delta Tocotrienols - Low Dose: 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhaoping Li, Professor | UCLA Department of Medicine/Center for Human Nutrition | 310-206-1987 | x61987 | zli@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Gamma Delta Tocotrienols - High Dose | Drug | 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks. |
|
|
| Sugar Pill | Drug | 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks. |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Gamma Delta Tocotrienols - High Dose |
33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Gamma Delta Tocotrienols - High Dose: 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks. |
| OG002 | Sugar Pill | 33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Sugar Pill: 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks. |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Gamma Delta Tocotrienols - High Dose | 33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Gamma Delta Tocotrienols - High Dose: 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Sugar Pill | 33 subjects with cholesterol level (>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Sugar Pill: 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |