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Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the Blood

NCT02634606 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-02-12

Study results available
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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.

Conditions

Interventions

DRUG

Gamma Delta Tocotrienols - Low Dose

250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.

DRUG

Gamma Delta Tocotrienols - High Dose

250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.

DRUG

Sugar Pill

250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Zhaoping Li, MD, PhD · University of California, Los Angeles

  • David Heber, MD, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-03-22
Primary Completion
2015-11-13
Completion
2015-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
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 NCT02634606 on ClinicalTrials.gov