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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05836909
• Other study ID #: Team Y
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: April 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Swisse plus cholesterol capsule
Swisse plus cholesterol capsule per day orally for 12 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
China	SunYat-senU	Guanzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Lili Yang	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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