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

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Swisse plus cholesterol capsule

Placebo

About this trial

This is an interventional prevention trial for Hypercholesterolemia

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age: 30-50 years old. Non-obese individuals: 18.5 ≤ BMI < 28. Total cholesterol levels ranging from marginal increase to increase: 6.2> TC ≥ 5.2 mmol/L (200 mg/dL). Exclusion Criteria: Currently being pregnant or breast-feeding or planning to become pregnant. Having severe complications of diabetes mellitus as well as any forms of cardiovascular diseases, tumor, liver diseases and kidney diseases. History (past 3 months) of intake of lipid-lowering or anti-diabetic health care products. Having hemorrhagic diathesis (high bleeding tendencies) or currently taking aspirin. Unwilling/unable to draw blood due to physical/personal reasons. History (past 1 month) of surgery. 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). History (past 2 weeks) of taking supplements containing red yeast rice, phytosterol ester or lycopene. Unqualified outcomes of safety measures at baseline.

Sites / Locations

SunYat-senU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Swisse Plus cholesterol capsules

placebo contral

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05836909

First Posted

April 19, 2023

Last Updated

June 16, 2023

Sponsor

Lili Yang

Collaborators

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05836909

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 1, 2023 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lili Yang

Collaborators

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Swisse Plus cholesterol capsules

Arm Type

Experimental

Arm 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

Arm Title

placebo contral

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Swisse plus cholesterol capsule

Intervention Description

Swisse plus cholesterol capsule per day orally for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in levels of total cholesterol

Description

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.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 30-50 years old. Non-obese individuals: 18.5 ≤ BMI < 28. Total cholesterol levels ranging from marginal increase to increase: 6.2> TC ≥ 5.2 mmol/L (200 mg/dL). Exclusion Criteria: Currently being pregnant or breast-feeding or planning to become pregnant. Having severe complications of diabetes mellitus as well as any forms of cardiovascular diseases, tumor, liver diseases and kidney diseases. History (past 3 months) of intake of lipid-lowering or anti-diabetic health care products. Having hemorrhagic diathesis (high bleeding tendencies) or currently taking aspirin. Unwilling/unable to draw blood due to physical/personal reasons. History (past 1 month) of surgery. 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). History (past 2 weeks) of taking supplements containing red yeast rice, phytosterol ester or lycopene. Unqualified outcomes of safety measures at baseline.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lili Yang, Professor

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

SunYat-senU

City

Guanzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial