Berberine's Effects on Lipids and Lipoproteins in Hyperlipidemic Chinese Women
Berberine
+ Placebo
Hyperlipidemias+2
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
Prevention Study
Summary
Study start date: August 1, 2024
Actual date on which the first participant was enrolled.This study aims to explore how the supplement berberine affects cholesterol levels and certain proteins related to cholesterol in the body, with a focus on potential differences between men and women. The study targets Chinese women in Hong Kong who have high cholesterol levels, also known as hyperlipidemia. Researchers are particularly interested in understanding if berberine can improve levels of total cholesterol, LDL, HDL, and triglycerides, among other factors, and if these effects vary between sexes. This research is important because finding effective treatments for high cholesterol can help prevent heart disease and other related health issues. Participants in the study will be divided into two groups. One group will receive berberine, while the other will receive a placebo, which is a harmless pill with no active ingredients. Both groups will take their assigned treatment twice a day for 12 weeks. Blood samples will be collected at the start, after 8 weeks, and again at the end of the 12-week period to measure changes in cholesterol and related proteins. The study will use a method called intention-to-treat analysis to ensure that the results are comprehensive and reliable, analyzing the effects of berberine across the entire period.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 20 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Women, who are: 1. aged 20 to 65 years. 2. of Chinese ethnicity. 3. with hyperlipidemia, defined as TG greater than 150 mg/dl (1.70 mmol/L), total cholesterol greater than 200 mg/dl (5.16 mmol/L), and/or LDL-cholesterol greater than 100 mg/dl (2.58 mmol/L). 4. willing to make return visits. 5. not currently receiving hormone replacement therapy or medications/pills containing hormones (such as hormonal contraception or hormone replacement therapy) in the past 12 months. 6. not currently taking berberine or nutraceuticals that contain berberine. 7. free of any congenital diseases, including familial hypercholesterolemia. 8. free of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. G6PD will be tested using G6PD rapid diagnostic tests. 9. free of hemolytic anemia. 10. free of any infectious diseases, e.g., seasonal influenza. 11. without liver/renal diseases. 12. not pregnant or planning to get pregnant in the next three months. Pregnancy will be ruled out using HCG ULTRA pregnancy tests. 13. not currently breastfeeding. Exclusion Criteria: * All men, and women who did not meet the aforementioned inclusion criteria and/or were unable or unwilling to provide consent.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
School of Public Health, The University of Hong Kong
Hong Kong, Hong KongOpen School of Public Health, The University of Hong Kong in Google Maps