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

Primary Purpose

Hypercholesterolemia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gamma Delta Tocotrienols - Low Dose
Gamma Delta Tocotrienols - High Dose
Sugar Pill
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Cholesterol

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to read, speak, and understand English
  • Male or female, 35-70 years old (inclusive)
  • Total Fasting Plasma Cholesterol of >180 mg/dl
  • Currently taking statin medications.
  • Willing to maintain AHA Step 1 diet for the duration of the study.

Exclusion Criteria:

  • Any subject who is taking vitamin E supplements or taking any antibiotics or other medication or dietary supplement which could interfere with the action of tocotrienols.
  • Any subject who is taking cholesterol lowering medications other than statins.
  • Any subject who has lost >5% of their body weight during the past 3 months.
  • Any subjects with a history of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatitis or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as BP >160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
  • Major surgery within 12 weeks prior to subject randomization and/or screening, especially cardiac surgery
  • Is currently a smoker who has a therapeutic plan to quit smoking anytime during the study period; or if not a current smoker, has quit smoking within the past 3 months.
  • Known HIV positive or known immunocompromised condition (e.g. MV, organ transplantation, treatment with immunosuppressant medications).
  • Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
  • Currently receiving systemic chemotherapy and/or radiotherapy.
  • Active bleeding.
  • Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
  • In the opinion of the study investigator has a risk of non-compliance with study procedures, or cannot read, understand or complete study related materials.

Sites / Locations

  • UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Gamma Delta Tocotrienols - Low Dose

Gamma Delta Tocotrienols - High Dose

Sugar Pill

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 26, 2014
Last Updated
January 23, 2019
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02634606
Brief Title
Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the Blood
Acronym
TRF
Official Title
Effects of a Tocotrienol-Enriched Fraction of Palm Oil on Serum Lipids in Hypercholesterolemic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Unable to obtain supplement for this study. Unable to recruit.
Study Start Date
March 22, 2011 (Actual)
Primary Completion Date
November 13, 2015 (Actual)
Study Completion Date
November 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Cholesterol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gamma Delta Tocotrienols - Low Dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Gamma Delta Tocotrienols - High Dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gamma Delta Tocotrienols - Low Dose
Other Intervention Name(s)
Tocotrienol-enriched Fraction of Palm Oil (TRF)
Intervention Description
250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Gamma Delta Tocotrienols - High Dose
Other Intervention Name(s)
Tocotrienol-enriched Fraction of Palm Oil (TRF)
Intervention Description
250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Sugar Pill
Other Intervention Name(s)
Placebo
Intervention Description
250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks.
Primary Outcome Measure Information:
Title
Change in LDL Cholesterol Over Time Between the 3 Groups
Description
Mixed-effects regression models will be used to evaluate the change in LDL cholesterol over time between the 3 groups
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to read, speak, and understand English Male or female, 35-70 years old (inclusive) Total Fasting Plasma Cholesterol of >180 mg/dl Currently taking statin medications. Willing to maintain AHA Step 1 diet for the duration of the study. Exclusion Criteria: Any subject who is taking vitamin E supplements or taking any antibiotics or other medication or dietary supplement which could interfere with the action of tocotrienols. Any subject who is taking cholesterol lowering medications other than statins. Any subject who has lost >5% of their body weight during the past 3 months. Any subjects with a history of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatitis or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as BP >160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination. Major surgery within 12 weeks prior to subject randomization and/or screening, especially cardiac surgery Is currently a smoker who has a therapeutic plan to quit smoking anytime during the study period; or if not a current smoker, has quit smoking within the past 3 months. Known HIV positive or known immunocompromised condition (e.g. MV, organ transplantation, treatment with immunosuppressant medications). Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia. Currently receiving systemic chemotherapy and/or radiotherapy. Active bleeding. Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. In the opinion of the study investigator has a risk of non-compliance with study procedures, or cannot read, understand or complete study related materials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoping Li, MD, PhD
Organizational Affiliation
UCLA Department of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Heber, MD, PhD
Organizational Affiliation
UCLA Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Human Nutrition, 900 Veteran Avenue, WH 14-187
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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