None listed
Conditions
Interventions
Intervention1: Milk-and legume-based Nutritional supplement: The nutritional supplement is a multigrain food based mix which will contain cereals, pulses, milk, oil, sugar or jaggery. The milk based w
Sponsors
DBT India Alliance The Wellcome Trust
Eligibility
Inclusion criteria
Inclusion criteria: Situational Analysis and Acceptability study 1.Infants in the age range of 6 months to 3years on complementary feeding. Efficacy Trial 1. Age: healthy infants aged 6-9 month 2. Exclusively or Predominantly Breastfed 3. Consented: Understanding of the study and willingness to participate as evidenced by subject’s parents and/or legal guardian’s voluntary written informed consent and has received a signed and dated copy of the informed consent form. 4. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: Situational Analysis 1. Infants with diagnosed chronic medical or surgical conditions impairing growth. 2. Infants with congenital syndromes impairing growth. 3. Infants with severe acute malnutrition. Acceptability study and Efficacy Trial 1. Infants with diagnosed chronic medical or surgical conditions impairing growth 2. Infants with congenital syndromes impairing growth 3. Infants with severe acute malnutrition 4. Children allergic to milk or legumes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To develop a modified milk-legume based multigrain mix as by performing a situational analysis on macro- and micronutrient quality of complementary feeds consumed by infants 6-12 months of age and their nutritional status. 2. Evaluate the acceptability of the improvised Nutrimix. 3.To determine the efficacy of milk and legume based protein formulations versus the regular Take Home Ration (THR) in infants for a period of 3 months along with IYCF and WASH counselling on linear growth.Timepoint: 1. One time. 2. One time. 3. Two times (Baseline and Endline) for Linear growth. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fecal microbiome 2. Plasma metabolome 3. Cognition (EEG & auditory & visual Event Related Potential) 4.Body composition (deuterium dilution technique)Timepoint: 1. 2 times(Baseline & end line) 2. 2 times (Baseline & End line) 3. 2 times (Baseline & End line) 4. 2 times (Baseline & End line) | — |
Countries
India
Contacts
Public ContactNirupama Shivakumar
St. Johns Medical College
Outcome results
None listed