Terminated
Objective: To evaluate cholesterol-suppressive actions of tocotrienol-enriched fractions in hypercholesterolemic human subjects.
Study Type:Interventional
Study Design: Randomized, double-blind, placebo-controlled
Subjects: Hypercholesterolemic subjects
Intervention: Gamma-Delta Tocotrienol (63 mg and 127 mg; Davos Life Science Pte Ltd)
Primary Outcome:
- Fasting cholesterol levels [time frame: baseline, 4, 8, 12 weeks]
- Total body fat [time frame: baseline, 4, 8 12 weeks]
Secondary Outcome:
- Genetic biomarkers for lipid metabolism
Methodology:
The cholesterol suppressive actions of tocotrienol-enriched formulations will be assessed in 99 hypercholesterolemic subjects 37 – 70 years of age, During a two-week run-in period, subjects will be asked to follow the American Heart Association Step 1 dietary regimen and to take a placebo capsule twice daily to determine their ability to comply with the diet and pill regimen. Their fasting cholesterol levels will be tested again after the two-week run-in period.
At this point, they will be randomly assigned to take either a placebo capsule or tocotrienol twice daily. Subjects will have body weight, waist circumference, fasting lipids and other biomarkers measured at 0, 4, 8 and 12 weeks