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Tocotrienol-enriched Fraction of Palm Oil (TRF) for Cholesterol Lowering (TOCO-CRYR Trial)
Phase 2 & 3
Waitlist Available
Led By Zhaopoing Li, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
TOCO-CRYR Trial 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.
TOCO-CRYR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of TRF vs. CRYR
TOCO-CRYR Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Tocotrienol-enriched Fraction of Palm Oil (TRF)Active Control2 Interventions
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.
Group II: CRYR + TRFActive Control1 Intervention
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.
Group III: Chinese Red Yeast Rice (CRYR)Active Control2 Interventions
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.
Group IV: Sugar PillPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,541 Previous Clinical Trials
10,267,043 Total Patients Enrolled
Zhaopoing Li, MD, PhDPrincipal InvestigatorUCLA Center for Human Nutrition
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