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Development of herbal extract in the form of ready-to-consume powder to modulate gut microbiota and metabolites for obesity and/or diabetic patients

Development of herbal extract in the form of ready-to-consume powder to modulate gut microbiota and metabolites for obesity and/or diabetic patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251111001
Enrollment
12
Registered
2025-11-11
Start date
2025-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Gut microbiota in obesity and type 2 diabetes. Obesity, type 2 diabetes mellitus, metabolic biomarkers, gut microbiota, Triphala extract

Interventions

The 2,000 mg of herbal extract will be used for treatment in the human gut model during 48 hours of fermentation time under controlled conditions: pH, temperature, and anaerobic.
Experimental Dietary Supplement

Sponsors

National Research Council of Thailand (NCRT)
Lead Sponsor
Fundamental fund Kasetsart University
Collaborator

Eligibility

Sex/Gender
Female
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Normal weight (BMI 18.5 to 24.9 kg/m2) 2.Obese (BMI more than 30 kg/m2) 3.T2DM - normal weight (Blood sugar level higher than 126 mg/dL, and BMI 18.5 to 24.9 kg/m2) 4.T2DM - Obese (Blood sugar level higher than 126 mg/dL, and BMI more than 30 kg/m2)

Exclusion criteria

Exclusion criteria: 1.History of intestinal surgery 2.Pregnancy/breastfeeding 3.The use of antibiotics and prebiotics within 3 months

Design outcomes

Primary

MeasureTime frame
The comparison of gut microbiota composition and metabolic activity before and after the intervention The gut microbiota will be analyzed by the shotgun metagenomic sequencing technique, and metabolic activity will be analyzed by metaproteomic and metabolomic analysis

Secondary

MeasureTime frame
The relationship between gut microbiota composition and metabolic activity before and after the intervention The integration of multi-omics data will be performed to proceed and visualize the relationships or correlations between gut microbiota and metabolic activity

Countries

Thailand

Contacts

Public ContactPaiboon Tunsagool

Biot KU

fagipot@ku.ac.th025625074

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026