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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Swisse plus cholesterol capsule
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 30-50 years old. Non-obese individuals: 18.5 ≤ BMI < 28. 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Swisse Plus cholesterol capsules<br>(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 | Dietary Supplement: Swisse plus cholesterol capsule<br>* Swisse plus cholesterol capsule per day orally for 12 weeks<br>|
| Placebo Comparator: placebo contral<br>The placebo is an excipient and the colos, flavor, shape and weight are same with the Swisse plus cholesterol capsule | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks |