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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Swisse plus cholesterol capsule

Intervention Type DIETARY_SUPPLEMENT

Swisse plus cholesterol capsule per day orally for 12 weeks

placebo contral

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Swisse plus cholesterol capsule

Swisse plus cholesterol capsule per day orally for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes