Lipid content in human milk is higher in overweight/obese infants

ISRCTN	ISRCTN18118021
DOI	https://doi.org/10.1186/ISRCTN18118021
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	0234/KEPK/IV/2018
Sponsor	Airlangga University
Funder	investigator initiated and funded

Submission date: 21/04/2022
Registration date: 26/04/2022
Last edited: 25/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Human milk (HM) is the best nutritional source for infant to support their growth during the first 6 months. Breast-fed infants were thinner compared to formula-fed infants, but some breast-fed infants are overweight/obese.
Aim: To investigate the macronutrient content of HM in normal infants and overweight/obese infants aged <12 months old.

Who can participate?
Mothers of normal/overweight/obese infants aged 1 -12 months, who breast-fed predominantly.

What does the study involve?
The researchers collect 1.5 ml of human milk from lactating women using breast pumps in a closed room for analysis.

What are the possible benefits and risks of participating?
Benefits: Mothers will be able to predict the optimum volume of human milk for the infants to achieve optimum growth without being overweight or obese.
Risks: there is no health risk for the participants (mothers and infants)

Where is the study run from?
RSUD Dr. Soetomo (Indonesia)

When is the study starting and how long is it expected to run for?
January 2018 to April 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Nur Aisiyah Widjaja, MD
nur.aisiyah.widjaja-2017@fk.unair.ac.id

Contact information

Dr Nur Aisiyah Widjaja
Principal investigator

Villa Kalijudan Indah N-33
Surabaya
60114
Indonesia

ORCID ID	0000-0001-7088-1278
Phone	+62 8123073379
Email	nur.aisiyah.widjaja-2017@fk.unair.ac.id

Study information

Primary study design	Observational
Study design	Observational case-control study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	Comparison of human milk macronutrient content between overweight and normal infants: a case-control study
Study objectives	is there a significant difference on the macronutrients content (energy, carbohydrate, protein and lipid) of human milk on overweight/obese infant (OW group) compared to normal infant (N group)?
Ethics approval(s)	Approved 25/04/2018, Health Research Ethics Committee of RSUD Dr. Soetomo Hospital (Jl. Mayjen Prof. Dr. Moestopo No. 6-8 Surabaya, Indonesia, +62 31-5501164; kepk@rsudrsoetomo.jatimprov.go.id), ref. 0234/KEPK/IV/2018
Health condition(s) or problem(s) studied	Comparison of human milk macronutrient content between overweight and normal infants
Intervention	Researchers collected the human milk using a breast pump in closed rooms at neonates wards, as much as 1.5 ml was syringed and replaced on a sterile tube with caps, and stored in an icebox until the analysis using MIRIS was performed. The measurement of HM components was performed in the nursery room using a human milk analyzer (HMA) (MIRIS®, Uppsala, Sweden) with an accuracy of <0.1 g/100 ml. The samples of human milk were divided into 2 groups: normal (N group) and overweight/obese (OW group) according to the nutritional status of infants, determined by a pediatrician (the researcher/Nur Aisiyah Widjaja).
Intervention type	Other
Primary outcome measure(s)	Measured using a human milk analyzer (HMA) (MIRIS®) at a single time point: 1. Carbohydrate content of milk 2. Lipid content of milk 3. Energy content of milk
Key secondary outcome measure(s)	Measured using a human milk analyzer (HMA) (MIRIS®) at a single time point: 1. Protein content of milk
Completion date	30/04/2018

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	1 Month
Upper age limit	12 Months
Sex	All
Target sample size at registration	40
Total final enrolment	20
Key inclusion criteria	1. Healthy lactating mother and does not consume steroids, drugs, alcohol, or a smoker 2. Healthy infant with nutritional status: normal, overweight or obese, aged 1-12 months old 3. Eager to participate in the study
Key exclusion criteria	1. Infants with growth deliration (underweight/ severely underweight, stunted/ severely stunted, wasted/ severely wasted) 2. Medically ill (infection, non infection)
Date of first enrolment	25/04/2018
Date of final enrolment	29/04/2018

Locations

Countries of recruitment

Indonesia

Study participating centre

RSUD Dr. Soetomo

Jl. Mayjen Prof. Dr. Moestopo No. 6-8
Surabaya
60286
Indonesia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/04/2022: Trial's existence confirmed by Health Research Ethics Committee of RSUD Dr. Soetomo Hospital