Effect of riceberry rice consumption on metabolic responses and body composition in obese children and adolescents
Phase 2
Recruiting
- Conditions
- Children and adolescents with exogenous obesity that is defined by BMI-for-age z-score at median+2SD and abovePediatric obesity, rice, dyslipidemias, body composition
- Registration Number
- TCTR20230815002
- Lead Sponsor
- none
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
1. WHO BMI-for-age z-score greater than median+3SD
2. Diagnosed with exogenous obesity
3. Achieve consent from parents for blood sampling and assessment of body composition
4. Agree to document food record and be followed up through regular phone calls
Exclusion Criteria
1. Pathological obesity
2. Presence of other co-morbidities not related to exogenous obesity
3. Diagnosed with Blount's disease or slipped capital femoral epiphysis
4. Diagnosed with diabetes mellitus
5. Allergic to riceberry rice or white rice
6. Receive medication that intefere with blood glucose and lipid profiles
7. Smoking
8. Presence of visual or hearing impairment
9. Inability to understand Thai language
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method lipid profiles 0 and 6 weeks plasma lipid levels
- Secondary Outcome Measures
Name Time Method Changes in weight, height, and BP 0 and 6 weeks weighing scale, stadiometer, sphygmomanometer,Changes in body composition 0 and 6 weeks BIA and DEXA,Markers of inflammation, oxidative stress, anti-oxidant capacity, adipokines, and hepcidin 0 and 6 weeks blood analysis,Changes in blood glucose and insulin 0 and 6 weeks Blood analysis,Anthocyanins consumption from rice random sampling throughout intervention period pH-differential method,Association of anthocyanins consumption and markers of inflammation, oxidative stress, anti-oxidant capacity, adipokines, and hepcidinchanges in throughout intervention period (anthocyanins); 0 and 6 weeks (markers) pH-differential method and blood analysis,Body composition 0 and 6 weeks BIA vs DEXA