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Pilot study to optimize the level of protein in products for Indian primary school children

Pilot study to optimize the level of protein in products for Indian primary school children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/12/007564
Enrollment
100
Registered
2016-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: A legume based micronutrient-supplemented product containing 12g Protein: A legume base Micronutrient-supplemented product fortified with 12g protein 2 times per day (Mid morning and po

Sponsors

Jamsetji Tata Trust
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1.Anthropometry measurements - height, weight, waist circumference and mid upper arm circumference 2.Intestinal microbiota stool sample 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

MeasureTime frame
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.

Countries

India

Contacts

Public ContactDr Maria Pauline

St. Johns National Academy of health sciences

mariapaulinejoe@gmail.com9844269436

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 28, 2026