Efficacy and safety of black pepper in lowering blood lipid levels in patients with dyslipidemia

Phase 2

Completed

• Conditions: Patients with dyslipidemia; black pepper, blood lipid levels, dyslipidemia

• Registration Number: TCTR20240618010
• Lead Sponsor: MFU research funding

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-12-08
• Study Start: 2024-06-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Volunteers will be eligible to participate in the research if they meet the following criteria:
1. Volunteers of both genders
1.1) Aged between 20-34 years with abnormal blood lipid levels, specifically LDL-C levels between 130-189 mg/dL, HDL-C levels less than 40 mg/dL in females or less than 50 mg/dL in males, and triglycerides levels < 400 mg/dL, or
1.2) Aged between 35-60 years with abnormal blood lipid levels, specifically LDL-C levels between 100-130 mg/dL, HDL-C levels less than 40 mg/dL in females or less than 50 mg/dL in males, and triglycerides levels < 400 mg/dL
2. Body mass index (BMI) between 18-35 kg/m2
3. Diagnosed as a first-time high blood cholesterol patient by the current physician
4. At risk of heart and vascular diseases with a 10-year risk assessment using the Thai CV Risk Score of less than 10%
5. Effective communication skills
6. Willing and able to comply with the study requirements

Exclusion Criteria

Volunteers will not be eligible to participate in the research if they have:
1. Abnormal blood lipid levels due to hypothyroidism, nephrotic syndrome, or impaired kidney function (serum creatinine > 1.5 milligrams per deciliter), or have Type 1 or uncontrolled Type 2 diabetes.
2. Consumed other herbal remedies, medications, or dietary supplements affecting blood lipid levels such as steroids, tegretol, cyclosporine, fish oil, fibrates, cholesterol absorption inhibitors, niacin, bile acid sequestrants, statins, probucol, thiazides, progestogens, estrogens, testosterone, beta-blockers, glucocorticoids, etc., that cannot be discontinued.
3. Systolic blood pressure greater than or equal to 130 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 80 mm Hg.
4. Not taken antihypertensive medications or heart disease medications.
5. Participated in other research projects (except for non-interfering studies such as surveys).
6. A history of allergy to black pepper or other herbal remedies.
7. High-risk factors for heart and vascular diseases, including existing coronary artery disease and other conditions equivalent to heart disease, such as ischemic stroke, transient ischemic attack, peripheral artery disease, aortic aneurysm, etc.
8. Liver cancer or liver function greater than the standard criteria, or impaired kidney function defined as a glomerular filtration rate (GFR) less than 60 milliliters per minute per 1.73 square meters (ml/min/1.73 m2).
9. Taken weight-reducing medications in the past 6 months.
10. Engaged in regular strenuous physical activity.
11. Strictly controlled their diet.
12. Pregnant, planning to become pregnant, breastfeeding, or unwilling to use medically acceptable birth control methods while participating in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lipid profile at week o (baseline) and week 12 (the end of study) lab investigation

Secondary Outcome Measures

Name	Time	Method
iver and renal function tests at week 0 (baseline) and week 8 lab investigation,Adverse events at week o (baseline), week 8, and week 12 (the end of study) Interview