Effect of inulin on gut microbiome: a randomized, double-blind, placebo-controlled clinical trial
Phase 2
Recruiting
- Conditions
- Effect of inulin on gut microbiomeinulin, prebiotics, gut microbiome, microbiome, function food
- Registration Number
- TCTR20240802003
- Lead Sponsor
- Fuji Nihon Thai Inulin Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
1. Age 18-65 years
2. Healthy volunteers with no underlying medical conditions
Exclusion Criteria
1.The participants experienced adverse effects from inulin.
2.The participants experienced adverse effects from maltodextrin.
3.Pregnant and lactating women.
4.Took antibiotics within 1 week before joining the research project.
5.History of abnormal bowel movements.
6.History of high blood sugar, abnormal kidney function, or abnormal liver function.
7.Took probiotic supplements or consumed probiotic food products within 1 month before joining the research project.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of gut microbiome between inulin and control groups 0, 4 weeks Stool examination for gut microbiome
- Secondary Outcome Measures
Name Time Method 1) Bowel movement, 2) Quality of life, 3) Complications 0, 4 weeks 1) Stool record book, 2) Questionnaire of bowel movement, 3) Adverse effects