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

• Sponsor: Lili Yang (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05836909
• Collaborator: Sun Yat-sen University (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Dietary Supplement: Swisse plus cholesterol capsule; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SunYat-senU	Guanzhou	Guangdong	China	510080

Sponsors and Collaborators

• Lili Yang
• Sun Yat-sen University

Investigators

• Study Chair: Lili Yang, Professor, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lili Yang, Sun Yat-sen University, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05836909
• Other Study ID Numbers: Team Y
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypercholesterolemia; Dyslipidemias

Study Results

No Results Posted as of May 1, 2023