NCT05836909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

April 19, 2023

Last Update Submit

June 16, 2023

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Swisse Plus cholesterol capsules

EXPERIMENTAL

(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

placebo contral

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Swisse plus cholesterol capsuleDIETARY_SUPPLEMENT

Swisse plus cholesterol capsule per day orally for 12 weeks

Swisse Plus cholesterol capsules
PlaceboDIETARY_SUPPLEMENT

Placebo

placebo contral

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SunYat-senU

Guanzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Cholesterol

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsMembrane LipidsLipids

Study Officials

  • Lili Yang, Professor

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
head of Department of Nutrition, School of Public Health, Sun Yat-sen University

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

May 1, 2023

Primary Completion

October 31, 2023

Study Completion

April 30, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

CN(1)