Effects of probiotics supplementation on changes in plasma lipid profile and other metabolic parameters in Thai adults with hypercholesterolemia

Phase 2

Completed

• Conditions: People with hypercholesterolemia, which is defined by serum LDL-C between 130 and 189 mg/dL and serum cholesterol greater than 200 mg/dL; Probiotics; Hypercholesterolemia; Short-chain fatty acids; Inflammation; Lactobacillus reuteri; Lactobacillus paracasei

• Registration Number: TCTR20240624007
• Lead Sponsor: Thailand Institute of Scientific and Technological Research (TISTR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-09-25
• Study Start: 2024-06-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum LDL-C Baseline, 6 weeks, and 12 weeks (at the end of intervention) Enzymatic method

Secondary Outcome Measures

Name	Time	Method
Serum total cholesterol, HDL-C, and triglyceride Baseline, 6 weeks, and 12 weeks (at the end of intervention) Enzymatic method, accelerator selective detergent method, and glycerol phosphate oxidase, respectively,Serum glucose and insulin Baseline, 6 weeks, and 12 weeks (at the end of intervention) Enzymatic method and electrochemiluminescence immunoassay (ECLIA), respectively,Serum hs-CRP, IL-1 beta, IL-6, IL-10, TNF-alpha Baseline, 6 weeks, and 12 weeks (at the end of intervention) Particle enhanced immunoturbidimetry and enzyme-linked immunosorbent assay (ELISA),Fecal short chain fatty acids Baseline and 12 weeks (at the end of intervention) GC-MS/MS