A Randomized, Double-blind, Placebo-controlled Trial of Using Red Yeast Rice, Phytosterol Esters and Lycopene in Combination for Regulating Lipid Metabolism of Guangzhou Individuals With Dyslipidemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in levels of total cholesterol
Study Overview
Brief Summary
The objective of this study is to evaluate the effect of using red yeast rice, phytosterol esters and lycopene in combination for 12 weeks on improving the glycolipid metabolism of Guangzhou individuals with dyslipidemia. Our hypothesis is that when compared with placebo, red yeast rice, phytosterol esters and lycopene together as supplements would lead to greater improvements in lipid metabolism (including lipid profiles and parameters ) in participants after 12 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 30-50 years old.
- •Non-obese individuals: 18.5 ≤ BMI <
- •Total cholesterol levels ranging from marginal increase to increase: 6.2> TC ≥ 5.2 mmol/L (200 mg/dL).
Exclusion Criteria
- •Currently being pregnant or breast-feeding or planning to become pregnant.
- •Having severe complications of diabetes mellitus as well as any forms of cardiovascular diseases, tumor, liver diseases and kidney diseases.
- •History (past 3 months) of intake of lipid-lowering or anti-diabetic health care products.
- •Having hemorrhagic diathesis (high bleeding tendencies) or currently taking aspirin.
- •Unwilling/unable to draw blood due to physical/personal reasons.
- •History (past 1 month) of surgery.
- •History (past 1 month) of large amounts of oral or intravenous treatment of glucocorticoids (such as prednisone, methylprednisone, betamethasone, beclomethasone propionate, Dubossone, prednisone, hydrocodesone, dexamethasone).
- •History (past 2 weeks) of taking supplements containing red yeast rice, phytosterol ester or lycopene.
- •Unqualified outcomes of safety measures at baseline.
Arms & Interventions
Swisse Plus cholesterol capsules
(the main components are red yeast rice, phytosterol esters and lycopene)，the capsule is orally taken twice a day,two,tablets at a time 12 weeks
Intervention: Swisse plus cholesterol capsule (Dietary Supplement)
placebo contral
The placebo is an excipient and the colos, flavor, shape and weight are same with the Swisse plus cholesterol capsule
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change in levels of total cholesterol
Time Frame: 12 weeks
At baseline, 4 weeks, 8 weeks and 12 weeks, bloods samples will be drawn and levels of total cholesterol will be determined in the two groups.
Secondary Outcomes
No secondary outcomes reported
Investigators
Lili Yang
head of Department of Nutrition, School of Public Health, Sun Yat-sen University
Sun Yat-sen University