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
Conditions
Interventions
L. paracasei TISTR 2593 capsule, which received from the Expert Center of Innovative Health Food, Thailand Institute of Scientific and Technological Research, Thailand, at a daily dose of 1.05 g x 10
Probiotic Lactobacillus paracasei,Probiotic Lactobacillus reuteri,Placebo
Sponsors
Thailand Institute of Scientific and Technological Research (TISTR)
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum LDL-C Baseline, 6 weeks, and 12 weeks (at the end of intervention) Enzymatic method | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactPennapa Chonpathompikunlert
Thailand Institute of Scientific and Technological Research (TISTR)
Outcome results
None listed