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

Lili Yang

Status: Invitation-only

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Swisse plus cholesterol capsule; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05836909

Team Y

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Swisse Plus cholesterol capsules

Experimental group

Description:

(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

Treatment:

Dietary Supplement: Swisse plus cholesterol capsule

placebo contral

Placebo Comparator group

Description:

The placebo is an excipient and the colos, flavor, shape and weight are same with the Swisse plus cholesterol capsule

Treatment:

Dietary Supplement: Placebo