Lipid content in human milk is higher in overweight/obese infants
| ISRCTN | ISRCTN18118021 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18118021 |
| Secondary identifying numbers | 0234/KEPK/IV/2018 |
- 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
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
Principal Investigator
Villa Kalijudan Indah N-33
Surabaya
60114
Indonesia
 ORCID ID |
0000-0001-7088-1278 |
|---|---|
| Phone | +62 8123073379 |
| nur.aisiyah.widjaja-2017@fk.unair.ac.id |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 |
| Secondary outcome measures | Measured using a human milk analyzer (HMA) (MIRIS®) at a single time point: 1. Protein content of milk |
| Overall study start date | 02/01/2018 |
| Completion date | 30/04/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 12 Months |
| Sex | Both |
| Target number of participants | 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
Surabaya
60286
Indonesia
Sponsor information
University/education
Kampus A UNAIR
Jl. Mayjen Prof. Dr. Moestopo No.47
Pacar Kembang
Kec. Tambaksari
Kota Surabaya
Jawa Timur
Surabaya
60132
Indonesia
| Phone | +62 31 5020251 |
|---|---|
| dekan@fk.unair.ac.id | |
| Website | http://unair.ac.id/ |
"ROR" |
https://ror.org/04ctejd88 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
25/04/2022: Trial's existence confirmed by Health Research Ethics Committee of RSUD Dr. Soetomo Hospital
