Testing Probiotic Supplements for Improving Metabolism and Liver Health in People with Obesity

Effect of Dietary Supplement with Lactobacillus zeae TISTR 2529 and Lactobacillus reuteri TISTR 2736 on Metabolic Parameters and Fatty Liver in Obese Volunteer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250805002

Enrollment

Registered

2025-08-05

Start date

2023-08-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants must present at least two of the following metabolic risk factors: elevated triglycerides (more than 150 mg/dL), low HDL cholesterol (less than 40 mg/dL for men or less than 50 mg/dL for women), high blood pressure (more than 130/85 mmHg or on antihypertensive medication), or elevated fasting glucose (more than 100 mg/dL or on antidiabetic treatment). Additionally, all participants must have a confirmed diagnosis of fatty liver, determined by FibroScan, ultrasound, MRI, or liver bio

Interventions

Participants take the probiotics daily and avoid antibiotics within 2 hours post-ingestion. Usual diets are maintained, avoiding other probiotic supplements. Follow-ups at Day 45 and Day 90 include re

Experimental Dietary Supplement,Placebo Comparator Dietary Supplement

Probiotic (Lactobacillus zeae TISTR 2529 and Lactobacillus reuteri TISTR 2736, 1:1 ratio)),Placebo

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age 20-50 years 2. At least 2 of the following 4 metabolic abnormalities (Triglycerides more than 150 mg/dL, HDL less than 40 mg/dL (men) or less than 50 mg/dL (women), Blood pressure more than 130/85 mmHg or on antihypertensives, or Fasting glucose more than 100 mg/dL or on antidiabetics 3. Diagnosed with fatty liver via FibroScan, ultrasound, MRI, or liver biopsy 4. No contraindications to FibroScan (e.g., pregnancy, pacemaker)

Exclusion criteria

Exclusion criteria: 1. Cirrhosis confirmed by liver biopsy or imaging 2. Liver disease diagnosis and/or AST/ALT >3x normal 3. Advanced cancer receiving chemotherapy 4. Conditions impairing compliance (e.g., psychiatric illness, substance abuse) 5. GI tract disorders 6. Use of weight-loss drugs or antibiotics within 3 months

Design outcomes

Primary

Measure	Time frame
TE, CAP Day 0 and Day 90 FibroScan,Body Composition Day 0, Day 45, and day 90 Anthropometry,Complete Blood Count Day 0, Day 45, and day 90 Hematological test,Blood Biochemical Indicators (Liver Function Tests, Renal Function Tests, Lipid Profiles, and Fasting blood glucose) Day 0, Day 45, and day 90 Hematological test,Adipose Tissue Function (Adiponectin) Day 0, Day 45, and day 90 Enzyme-Linked Immunosorbent Assay (ELISA),Fasting Insulin Day 0, Day 45, and day 90 Enzyme-Linked Immunosorbent Assay (ELISA),HOMA-IR Day 0, Day 45, and day 90 Calculation Formula	—

Measure

Time frame

TE, CAP Day 0 and Day 90 FibroScan,Body Composition Day 0, Day 45, and day 90 Anthropometry,Complete Blood Count Day 0, Day 45, and day 90 Hematological test,Blood Biochemical Indicators (Liver Function Tests, Renal Function Tests, Lipid Profiles, and Fasting blood glucose) Day 0, Day 45, and day 90 Hematological test,Adipose Tissue Function (Adiponectin) Day 0, Day 45, and day 90 Enzyme-Linked Immunosorbent Assay (ELISA),Fasting Insulin Day 0, Day 45, and day 90 Enzyme-Linked Immunosorbent Assay (ELISA),HOMA-IR Day 0, Day 45, and day 90 Calculation Formula

—

Secondary

Measure	Time frame
Inflammatory Response (CRP, IL-6, and TNF-alpha)) Day 0 and Day 90 Enzyme-Linked Immunosorbent Assay (ELISA),Oxidative Stress (MDA) Day 0 and Day 90 Thiobarbituric acid reactive substances (TBARS) Assay	—

Countries

Thailand

Contacts

Public ContactKongsak Boonyapranai

Chiang Mai University

kongsak.b@cmu.ac.th053942508

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026