Efficacy of probiotic food supplement in human volunteers with risk factors of metabolic syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220621002

Enrollment

120

Registered

2022-06-21

Start date

2021-03-01

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

Risk of metabolic syndrome patients such as HbA1c 5.7%-6.4%, LDL more than 130 mg/dl, triglyceride more than 150 mg/dl, BMI more than 23 Probiotic Bifidobacterium animalis TA1 Lactobacillus reuteri TF7 Metabolic syndrome

Interventions

oral Lactobacillus reuteri TF7 capsule twice daily ,oral Bifidobacterium animalis TA1 capsule twice daily ,oral Lactobacillus reuteri TF7 capsule twice daily combined with oral Bifidobacterium animal

Experimental Dietary Supplement,Experimental Dietary Supplement,Experimental Dietary Supplement,Placebo Comparator No treatment

oral Lactobacillus reuteri TF7 capsule,oral Bifidobacterium animalis TA1 capsule,oral Lactobacillus reuteri TF7 combined with oral Bifidobacterium animalis TA1 capsule ,Isomalt

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-60 years both men and women 2. HbA1c 5.7%-6.4% 3. LDL more than 130 mg/dl 4. Triglyceride more than 150 mg/dl 5. BMI more than 23

Exclusion criteria

Exclusion criteria: 1. Underlying diseases of diabetes, hypertension, chronic kidney disease, any cancers, immunodeficiency 2. Current taking lipid-lowering drugs 3. Current taking antibiotics 4. Smoking 5. Allergic to probiotics 6. Pregnancy and breastfeeding 7. Alcohol addicted

Design outcomes

Primary

Measure	Time frame
Cholesterol (LDL ) follow up every 4 week for 12 weeks Blood level of LDL	—

Secondary

Measure	Time frame
Triglyceride follow up every 4 week for 12 weeks Blood level for triglyceride,HbA1c follow up every 4 week for 12 weeks Blood level for HbA1c,BMI (kg/m2 ) follow up every 4 week for 12 weeks BMI (kg/m2 ),Body Weight (kg) follow up every 4 week for 12 weeks Body Weight (kg) ,Gut microbiome At week 12 Stool examination	—

Countries

Thailand

Contacts

Public ContactMalai Taweechotipatr

Faculty of Medicine, Srinakharinwirot University

malai@g.swu.ac.th0860961314

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026