Pilot study to optimize the level of protein in products for Indian primary school childre
Not Applicable
- Registration Number
- CTRI/2016/12/007564
- Lead Sponsor
- Jamsetji Tata Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Parents willing to give an informed consent and subjects willing to give assent.
2.Boys and girls aged between 6-10 years.
3.Children with Z-scores of less than -2.0.
4.Mildly anemic (Hb <12 g/dL).
Exclusion Criteria
1.Recent history (3 months) of serious infections, injuries and/ or surgeries.
2.Use of any prescription medications.
3.Children consuming nutritional supplements and/ or health food drinks on a regular basis.
4.Food allergies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference <br/ ><br>2.Intestinal microbiota stool sample <br/ ><br>3.Serum, urine metabolomicsTimepoint: Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration.
- Secondary Outcome Measures
Name Time Method Micronutrient status: Hb, Serum folate, B12, ferritin, plasma iron, plasma zinc, renal and liver function testTimepoint: Two times during the study. 1. Baseline i.e before start of intervention administration. 2.During End line i.e after the last day of intervention administration.