Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the Blood
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Gamma Delta Tocotrienols - Low Dose; Gamma Delta Tocotrienols - High Dose; Sugar Pill
Intervention description: 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.; 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.; 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks.
Intervention MeSH terms: Tocotrienols; Vitamin E; Tocopherols
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cholesterol

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.
    

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.