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Effects of a Supplement Derived From Palm Oil on Cholesterol Levels and Chinese Red Yeast Rice in the Blood

NCT02142569 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2019-01-11

No results posted yet for this study

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.

Conditions

  • Cholesterol Lowering

Interventions

DRUG

Sugar Pill

Sugar Pills/Placebo 4 capsules/day for 12 weeks.

DRUG

Chinese Red Yeast Rice (CRYR)

CRYR 1200mg/day, including 6 mg mevinolin as Monacolin K (2 capsules) + placebo (2 capsules) for 12 weeks.

DRUG

CRYR + TRF

CRYR 1200mg/day, including 6 mg mevinolin as Monacolin K (2 capsules) + TRF 300mg/day including 60 mg tocotrienols (2 capsules) per day for 12 weeks.

DEVICE

Tocotrienol-enriched Fraction of Palm Oil (TRF)

TRF 300mg/day, including 60 mg tocotrienols (2 capsules) + placebo (2 capsules) per day for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Zhaopoing Li, MD, PhD · UCLA Center for Human Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-30
Primary Completion
2016-02-09
Completion
2016-02-09

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02142569 on ClinicalTrials.gov