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

NCT02634606 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: TOCO 11-000665
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Drug: Gamma Delta Tocotrienols - Low Dose

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.

Drug: Gamma Delta Tocotrienols - High Dose

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.

Drug: Sugar Pill

Interventions

Gamma Delta Tocotrienols - Low Dose DRUG

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

Also known as: Tocotrienol-enriched Fraction of Palm Oil (TRF)

Gamma Delta Tocotrienols - Low Dose

Gamma Delta Tocotrienols - High Dose DRUG

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

Also known as: Tocotrienol-enriched Fraction of Palm Oil (TRF)

Gamma Delta Tocotrienols - High Dose

Sugar Pill DRUG

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

Also known as: Placebo

Sugar Pill

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

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

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Sugars

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Zhaoping Li, Professor
• Organization: UCLA Department of Medicine/Center for Human Nutrition

zli@mednet.ucla.edu

310-206-1987

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• David Heber, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: December 18, 2015
• Study Start: March 22, 2011
• Primary Completion: November 13, 2015
• Study Completion: November 13, 2015
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-01

Locations

US (1)