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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05836909

Enrollment

Registered

2023-05-01

Start date

2023-05-01

Completion date

2024-04-30

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

DIETARY_SUPPLEMENTSwisse plus cholesterol capsule

Swisse plus cholesterol capsule per day orally for 12 weeks

DIETARY_SUPPLEMENTPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026