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

• Status: Terminated
• Trial end date: 2015-11-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Tocopherols; Tocotrienols; Vitamin E

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.