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

Not Applicable

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Swisse plus cholesterol capsule

• Registration Number: NCT05836909
• Lead Sponsor: Lili Yang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-28
• Study Start: 2023-05-01
• Study First Posted: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-10-31
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo contral	Placebo	The placebo is an excipient and the colos, flavor, shape and weight are same with the Swisse plus cholesterol capsule
Swisse Plus cholesterol capsules	Swisse plus cholesterol capsule	(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

Primary Outcome Measures

Name	Time	Method
Change in levels of total cholesterol	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.

Trial Locations

Locations (1)

SunYat-senU; 🇨🇳 Guanzhou, Guangdong, China