Health Condition 1: E440- Moderate protein-calorie malnutrition
Conditions
Interventions
Intervention1: Not Applicable as this is an observational study: Not Applicable as this is an observational study
Control Intervention1: Not Applicable.: Not Applicable.
Sponsors
Nestec Ltd
JSS Medical Research India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. All mothers who delivered term infants, either SGA or AGA 2. Mothers between 18 and 40 years of age inclusive, at the time of enrolment 3. Having decided to predominantly breast-feed their new born baby at least until 6 months of age 4. Having permanent residence at a maximum distance of 50km from the hospital/center of investigation for the duration of this study and being able to follow all the steps of this study 5. Willing to provide informed consent according to the requirements of local regulations.
Exclusion criteria
Exclusion criteria: 1. Preterm delivery ( 2. Currently participating or having participated in an interventional clinical trial during the last 4 weeks prior to the beginning of this study 3. Having a BMI >= 25.0 4. Chewing tobacco, smoking or drinking alcohol ( > 1 glass per day), consuming illicit drugs during pregnancy or/and duration of the study 5. Presenting any disease or medical condition which might prevent breast-feeding or collecting the human milk samples or for which breast-feeding is contraindicated 6. Having diabetes or gestational diabetes mellitus 7. Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease 8. Subject unable to comply with study procedures or unable to come to hospital for the study visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Milk samples will be collected longitudinally from the mothers will be enrolled for the characterization by modern analytical and state-of-the-art techniques. 2. Analyses of functional milk components, such as macronutrients (total fat, total protein, total lactose, total energy and total solid, crude proteins) and total protein analysis by BCA kit is planned.Timepoint: Throughout the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dietary intake will be assessed by a dietary questionnaire and analyzed by tool/books. Example-By use of â??Nutritive Value of Indian Foodsâ?? or a similar book/tool issued by National Institute of Nutrition Timepoint: Throughout the study period.;2. The maternal milk composition will be correlated longitudinally to motherâ??s diet, stage of lactation, type of delivery, sex of the infant, single/multiple birth, infant anthropometric measures (weight, length and head circumference), gestational age at birth and birth anthropometricsTimepoint: Throughout the study period.;3. Other parameters & functional milk components are considered as exploratory. Inclusion of these & other possible exploratory parameters will be assessed periodically or at end of study based on development of these analytical methodologies in India .Timepoint: Throughout the study period. | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Limited
Outcome results
None listed