The effects of healthy food derived from corn leaf dietary fiber on body weight and body mass index change in overweight volunteers
Phase 1
Completed
- Conditions
- Healthy conditionsDietary fiberpurple waxy corncorn leafbody weightbody mass indexBMIoverweight
- Registration Number
- TCTR20210806003
- Lead Sponsor
- ational Research Council of Thailand (NRCT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
1.Aged between 35-60 years old
2.Body Mass Index (BMI) more than 23 kg/m2
Exclusion Criteria
1. Volunteers who have been diagnosed with one of the following; cardiovascular diseases, respiratory diseases, neuropsychological diseases, liver disease (AST more than 64 U/L, ALT more than 50 U/L), Kidney disease (estimate GFR less than 90 ml/min), autoimmune disease, hematological disorder, cancer, and hypertension
2. Fasting Blood Sugar (FBS) after fasts for 8 hours more than 100 mg/dL
3. Volunteers who use supplements or any drug that affect the body weight, glucose, and lipid level before trial
4. Smoking more than 10 pieces/ day
5. Drinking alcohol more than 5 times/ day
6. Pregnancy or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body weight and body mass index 6 weeks Equipment
- Secondary Outcome Measures
Name Time Method The changes of hematological and clinical chemistry parameters 6 weeks Laboratory,Urinalysis 6 weeks Laboratory,HOMA-IR, AI, and Insulin 6 weeks Laboratory,Angiotensin converting enzyme (ACE) 6 weeks Elisa method,Advanced glycation end products (AGEs) 6 weeks Elisa method,The changes of electrocardiogram 6 weeks Electrocardiography,Stool examination (PH, Total lactic acid, Bifidobacterial, Short chain fatty acid) 6 weeks Laboratory,Safety evaluation 6 weeks Questionnaire