TCTR20240624007CompletedPhase 2
Effects of probiotics supplementation on changes in plasma lipid profile and other metabolic parameters in Thai adults with hypercholesterolemia
Thailand Institute of Scientific and Technological Research (TISTR)0 sites108 target enrollmentStarted: June 24, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 108
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Male or female, aged between 20 and 60 years, 2. People with hypercholesterolemia (total cholesterol >200 mg/dL and LDL-C 130-189 mg/dL), 3. Serum TG level less than 500 mg/dL, 4. Body mass index (BMI) between 18.5 and 30 kg/m2, 5. Not being pregnant or lactating woman, 6. Willing to receive probiotics continuously for 12 weeks, 7. Living in the central region of Thailand not less than 10 years
Exclusion Criteria
- •1. A diagnosis of diabetes, chronic liver disease, chronic kidney disease, cardiovascular disease, cancer, anemia, thyroid disease, or gastrointestinal tract disease, 2. Receiving steroids, antibiotics, or any medications which will potentially affect the lipid metabolism, such as statins, bile acid sequestering agents, cholesterol absorption inhibitors, nicotinic acid in the past month, 3. Receiving any dietary supplements such as fish oil, dietary fiber, plant sterol/stanol, soy protein, prebiotics, probiotics, black garlic, or ginseng in the past month, 4. Current involvement in a program related to lifestyle modification or ongoing dietary practices such as intermittent fasting, ketogenic diet, plant-based diet, 5. Unstable body weight, defined as a change of 5 kg within 2 months, 6. Smoking and/or drinking alcoholic beverages, 7. Have a history of allergic reaction to probiotic supplements and placebos such as maltodextrin, bovine gelatin capsules, etc.
Investigators
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