Regulation of Lipid Metabolism in Guangzhou Individuals With Dyslipidemia by Red Yeast Rice, Phytosterol Esters and Lycopene

Lili Yang80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

Swisse plus cholesterol capsuleDIETARY_SUPPLEMENT

Swisse plus cholesterol capsule per day orally for 12 weeks

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 30-50 years old. 2. Non-obese individuals: 18.5 ≤ BMI \< 28. 3. Total cholesterol levels ranging from marginal increase to increase: 6.2\> TC ≥ 5.2 mmol/L (200 mg/dL). Exclusion Criteria: 1. Currently being pregnant or breast-feeding or planning to become pregnant. 2. Having severe complications of diabetes mellitus as well as any forms of cardiovascular diseases, tumor, liver diseases and kidney diseases. 3. History (past 3 months) of intake of lipid-lowering or anti-diabetic health care products. 4. Having hemorrhagic diathesis (high bleeding tendencies) or currently taking aspirin. 5. Unwilling/unable to draw blood due to physical/personal reasons. 6. History (past 1 month) of surgery. 7. 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). 8. History (past 2 weeks) of taking supplements containing red yeast rice, phytosterol ester or lycopene. 9. Unqualified outcomes of safety measures at baseline.

Locations (1)

SunYat-senU

Guanzhou, Guangdong, China

Outcomes

Primary Outcomes

Change in levels of total cholesterol

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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