Human Milk Composition in Indian Mothers

NCT03061929 | Completed

• 1 other identifier: AL21
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 8

Brief Summary

Nutritional profile of mother's milk is influenced by various factors including environmental, dietary and nutritional status of the mother. Given the huge diversity noted in nutritional status and ethnic dietary patterns in Indian population, including pregnant and lactating mothers, it can be conceivably predicted to have an influence on milk composition. With the lack of recent literature addressing these, it is vital to understand and update the influence if any, of nutritional status and dietary patterns on nutritional quality of human milk. The proposed Human milk analysis clinical study in Indian mothers is aimed to achieve a more recent and updated database of nutritional profile of Indian mother's milk considering the dietary and regional influences and demographic differences which can play a key role in levels of nutrients in mother's milk. In order to incorporate the varied dietary patterns, milk samples will be collected from mothers recruited from 8 sites across the country and analysed for important nutrient levels.

Conditions

Breast Feeding

Outcome Measures

Primary Outcomes (1)

• Change in fat content of milk

  Fat content will be analyzed by standardized and modern analytical methods.

  from 15 days post-partum to 98 days post-partum

Secondary Outcomes (2)

• Change in fatty acid profile in mother's milk

  from 15 days post-partum to 98 days post-partum

• Assessment of dietary intake of macro and micronutrients by mother

  From 15 days post-partum to 98 days post-delivery

Study Arms (3)

Undernourised

Mother's with BMI less than 18.5

Normally Nourished

Mother's with BMI greater than or equal to 18.5 to less than or equal to 25.

Overnourished

Mother's with BMI over 25 to less than or equal to 35.

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

258 mother-infant pair subjects (86 per group) will be enrolled. The mothers will be normally-nourished or undernourished or over nourished based on pre-pregnancy measured BMI (kg/m2).

You may qualify if:

• Mother is at 33 to 42 weeks of pregnancy, is between 20 and 35 years of age and is contactable by telephone
• Mother is non smoker and non alcoholic.
• Mother has BMI 35 kg per m2 based on self reported pre pregnant weight or the earliest measured weight during the first trimester from the hospital record.
• Mother confirms her intention to breast feed for 4 months.
• Infant is a singleton with a gestational age of greater than 37 to 42 weeks and is able to feed from the mother normally.
• Infants born between 33 to 37 weeks, by definition are preterm, but is not declared very low birth weight by the pediatrician, and is able to feed from the mother normally.
• Infant is judged to be in good health in the opinion of the investigator.
• Mother or Legally Acceptable Representative has voluntarily signed and dated an Informed Consent Form, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.

You may not qualify if:

• An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential effects on infant's growth and or development. This includes but is not limited to suspected maternal substance abuse such as alcohol or drug.
• Mother has known gestational diabetes and/or a diagnosis of pre-eclampsia.
• Mother with contraindications to breastfeeding such as known HIV or conditions that can significantly interfere with breastfeeding such as serious illness as per investigator's judgment.
• Mother had a breast surgery.
• Mother and or newborn infant has major illness that requires intensive care admission 24 hours.
• Infant is advised to be kept in NICU and unable to feed from the mother for more than a week or has a medical history that is thought by the investigator to have potential effects on infant's growth and or development.
• Infant has major congenital anomaly in the PI's opinion
• Participation in another study that has not been approved as a concomitant study by AN.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (8)

MS Ramaiah Medical College and Hospital

Bangalore, 560054, India

Location

Sir Gangaram Hospital

Delhi, 110060, India

Location

Institute of Child Health

Kolkata, 700017, India

Location

Institute of Post Graduate Medical Education & Research and SSKM Hospital

Kolkata, 700020, India

Location

King George Medical College & University

Lucknow, 226003, India

Location

Cheluvumba Hospital

Mysore, 570021, India

Location

King Edward Memorial Hospital

Pune, 411011, India

Location

Sant Dnyadneshwar Medical Institute

Pune, 411030, India

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Deepti Khanna, Ph.D.

  Abbott Nutrition Research & Development

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 23, 2017
• Study Start: March 24, 2017
• Primary Completion: May 30, 2018
• Study Completion: June 30, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (8)