Effects of synbiotic supplementation on intestinal microbiota , antioxidant status and short chain fatty acids among pediatric obesity : A Randomized clinical trial
Phase 3
- Conditions
- The modulation of gut microbiota, metabolites, and short-chain fatty acids in obese Thai children while receiving synbiotics.obesity, synbiotic, prebiotic, probiotic, short chain fatty acids, metabolites, gut microbiota
- Registration Number
- TCTR20240321005
- Lead Sponsor
- Faculty of Medicine, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Age 7 to 18 years
2. BMI > median + 2SDs (WHO reference)
3. No history of pre-/pro-/ synbiotic supplementation or antibiotics use at least 4 weeks prior to participation.
Exclusion Criteria
1. Cow's milk protein allergy
2. Syndromic obesity
3. Endocrine causes of obesity (e.g. hypothyroidism, growth hormone deficiency)
4. Use of drugs that influence apetite or body weight (e.g. corticosteroids)
5. Attending other concurrent weight reduction programs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Short chain fatty acids At the time of enrollment and three months thereafter Measure in stool sample,Gut microbiota At the time of enrollment and three months thereafter Measure in stool sample
- Secondary Outcome Measures
Name Time Method Metabolites profile At the time of enrollment and three months thereafter Measure in serum: iNOS, IL-1B, MCP-1, LPS, LBP, MDA, TGF-B, FIZZ, Arginase, IL-10,Metabolic profiles At the time of enrollment and three months thereafter Measure in serum lipid profile, fasting blood sugar levels, and insulin levels