ObesityNCT05798676
Maternal Characteristics Associated With Child Growth and Adiposity
An observational study of Obesity and Obesity, Infant, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site in Argentina.
Trial summary
The goal of this observational study is to investigate the concentrations of leptin, insulin, liver expressed antimicrobial peptide 2 (LEAP2), and cortisol in plasma and breast milk and their relationship with eating behavior, growth, adiposity and with the levels of these hormones in infants, comparing mothers with… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Infant
- What is being tested?
- overweight/obesity
- How many people
- 130 participants
- Where
- 1 siteArgentina
- Study dates
- 2 May 2019to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Lactating women with pre-pregnancy normal weight and overweight or obesity recruited at the Mother and Healthy Children Outpatient Service, Instituto de Desarrollo e Investigaciones Pediátricas (IDIP), HIAEP "Sor María Ludovica", La Plata, Argentina.
Who may be able to join
- Lactating women with pre-pregnancy normal weight and overweight or obesity as described by the World Health Organization.
Who cannot join
- Diabetes (Type I or II or gestational)
- Multiple pregnancy
- Hypertensive disorders during pregnancy
- Delivery of pre-term infant (<37 weeks).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
La Plata, Buenos Aires, 1900
Maria F Andreoli, PhD, 54 221 4535901 ext. 1767, mfandreoli@gmail.com
Ana Kruger, BsC, 54 221 4535901 ext. 1767, krugluzana@gmail.com
About this study
Official title: Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood
The goal of this observational study is to investigate the concentrations of leptin, insulin, liver expressed antimicrobial peptide 2 (LEAP2), and cortisol in plasma and breast milk and their relationship with eating behavior, growth, adiposity and with the levels of these hormones in infants, comparing mothers with normal weight and with pre-pregnancy overweight/obesity. The main question[s] it aims to answer are:
- Are maternal hormones associated with child growth and adiposity
- Are maternal hormone receptors associated with child growth and adiposity
- Are infant hormones and their receptors associated with child growth and adiposity
- Are maternal and infant hormones and their receptors associated with child eating behavior Participants will provide milk and blood samples. Researchers will compare mothers with normal weight and with pre-pregnancy overweight/obesity to see if there are differences in child growth and adiposity .
- Conditions
- Obesity, Obesity, Infant
- Being tested
- overweight/obesity
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overweight/obesityOther
the consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied
| Study group | Role | What they receive |
|---|---|---|
| mothers with pre-pregnancy normal weight and their infants | mothers with pre-pregnancy normal weight according to World Health Organization will provide blood and milk samples | |
| mothers with pre-pregnancy overweight or obesity and their infants | mothers with pre-pregnancy overweight or obesity according to World Health Organization will provide blood and milk samples Receives: Other: overweight/obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
infant weight
weight in kilograms
Measured: from birth to 2 years old
infant height
height in centimeters
Measured: from birth to 2 years old
infant body mass index (BMI)
weight and height will be combined to report BMI in kg/m^2
Measured: from birth to 2 years old
infant upper arm circumference
upper arm circumference in centimeters
Measured: from birth to 2 years old
infant skinfold thickness
skinfold thickness in centimeters
Measured: from birth to 2 years old
infant blood leptin concentration
blood leptin concentration (ng/ml)
Measured: six months old
infant blood cortisol concentration
blood cortisol concentration (ug%)
Measured: six months old
infant saliva cortisol concentration
saliva cortisol (ug%)
Measured: six months old
infant blood insulin concentration
blood insulin concentration (uU/ml)
Measured: six months old
infant insulin receptor gene expression in peripheral blood mononuclear cells
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: six months old
infant leptin receptor gene expression in peripheral blood mononuclear cells
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: six months old
infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: six months old
infant blood LEAP2 concentration
blood LEAP2 concentration (pg/ml)
Measured: six months old
infant eating behavior assessed in a Taste acceptance test
Outcome Measures Infant taste acceptance was assessed using two complementary measures: an Ingestion Ratio (IR) and a Liking Ratio (LR). Sweet and fat taste acceptance were evaluated using a lactose solution (0.2 M) and a fat emulsion (3.5% w/v), respectively, with water used as a reference. During each test, infants were sequentially offered bottles containing water and the tastant. Intake volume was determined by weighing bottles before and after ingestion.
The IR was calculated as the volume of tastant consumed divided by the total volume of tastant plus water consumed, allowing comparison across infants by accounting for individual differences in sucking behavior.
The LR was based on a blinded experimenter's assessment of the infant's overall behavioral response using a standardized 5-point scale ranging from strong rejection to strong acceptance. Both ratios ranged from 0 to 1, with 0.5 indicating indifference relative to water.
Measured: at 18 month od
Secondary outcomes (11)
maternal blood leptin concentration
blood leptin concentration (ng/ml)
Measured: 15 days, three and six months postpartum
maternal milk leptin concentration
milk leptin concentration (ng/ml)
Measured: 15 days, three and six months postpartum
maternal blood insulin concentration
blood insulin concentration (uU/ml)
Measured: 15 days, three and six months postpartum
maternal milk insulin concentration
milk insulin concentration (uU/ml)
Measured: 15 days, three and six months postpartum
maternal blood cortisol concentration
blood cortisol concentration (ug%)
Measured: 15 days, three and six months postpartum
maternal milk cortisol concentration
milk cortisol concentration (ug%)
Measured: 15 days, three and six months postpartum
maternal insulin receptor gene expression in peripheral blood mononuclear cells
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: 15 days, three and six months postpartum
maternal leptin receptor gene expression in peripheral blood mononuclear cells
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: 15 days, three and six months postpartum
maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: 15 days, three and six months postpartum
maternal blood LEAP2 concentration
blood LEAP2 concentration (pg/ml)
Measured: 15 days, three and six months postpartum
maternal milk LEAP2 concentration
milk LEAP2 concentration (pg/ml)
Measured: 15 days, three and six months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start2 May 2019
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria F Andreoli, BsC, Principal investigator, Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798676
- Sponsor's protocol ID
- L2022
- Status last verified
- Dec 2025
- First submitted
- 23 Feb 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Lopez M, Faquini MS, Castrogiovanni D, Schioth H, Nicklaus S, Perello M, Andreoli MF. Milk and infant plasma hormone concentrations predict sweet and fat taste acceptance and later food intake. J Neuroendocrinol. 2026 Oct;38(10):e70282. doi: 10.1111/jne.70282.
PubMed 42823632Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Tournier A, Fasano MV, Andreoli MF. Human milk cortisol is inversely associated with infant BMI and mediates the association between maternal plasma and infant salivary cortisol concentrations. Int J Obes (Lond). 2025 Aug;49(8):1632-1641. doi: 10.1038/s41366-025-01815-4. Epub 2025 May 31.
PubMed 40450153Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Lopez M, Tournier A, Castrogiovanni D, Heredia F, Llovera R, Schioth HB, Perello M, Andreoli MF. The Concentration of Liver-Expressed Antimicrobial Peptide 2 in Human Milk and Infant Plasma Is Positively Associated with Adiposity and Body Weight in the First Year of Life. J Nutr. 2024 Nov;154(11):3388-3399. doi: 10.1016/j.tjnut.2024.09.008. Epub 2024 Sep 12.
PubMed 39277116
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood
- ClinicalTrials.gov ID
- NCT05798676
- Acronym / sponsor ID
- L2022
- Conditions
- Obesity, Obesity, Infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. ViteriUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate the concentrations of leptin, insulin, liver expressed antimicrobial peptide 2 (LEAP2), and cortisol in plasma and breast milk and their relationship with eating behavior, growth, adiposity and with the levels of these hormones in infants, comparing mothers with normal weight and with pre-pregnancy overweight/obesity. The main question[s] it aims to answer are:
- Are maternal hormones associated with child growth and adiposity
- Are maternal hormone receptors associated with child growth and adiposity
- Are infant hormones and their receptors associated with child growth and adiposity
- Are maternal and infant hormones and their receptors associated with child eating behavior Participants will provide milk and blood samples. Researchers will compare mothers with normal weight and with pre-pregnancy overweight/obesity to see if there are differences in child growth and adiposity .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mothers with pre-pregnancy normal weight and their infants | – | –mothers with pre-pregnancy normal weight according to World Health Organization will provide blood and milk samples |
| mothers with pre-pregnancy overweight or obesity and their infants | – | Other: overweight/obesitymothers with pre-pregnancy overweight or obesity according to World Health Organization will provide blood and milk samples |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Lactating women with pre-pregnancy normal weight and overweight or obesity recruited at the Mother and Healthy Children Outpatient Service, Instituto de Desarrollo e Investigaciones Pediátricas (IDIP), HIAEP "Sor María Ludovica", La Plata, Argentina.
Key inclusion criteria (1 listed)
- Lactating women with pre-pregnancy normal weight and overweight or obesity as described by the World Health Organization.
Key exclusion criteria (4 listed)
- Diabetes (Type I or II or gestational)
- Multiple pregnancy
- Hypertensive disorders during pregnancy
- Delivery of pre-term infant (<37 weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| overweight/obesitythe consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied | Other | mothers with pre-pregnancy overweight or obesity and their infants |
Primary outcome
infant weight
Time frame: from birth to 2 years old
weight in kilograms
infant height
Time frame: from birth to 2 years old
height in centimeters
infant body mass index (BMI)
Time frame: from birth to 2 years old
weight and height will be combined to report BMI in kg/m^2
infant upper arm circumference
Time frame: from birth to 2 years old
upper arm circumference in centimeters
infant skinfold thickness
Time frame: from birth to 2 years old
skinfold thickness in centimeters
infant blood leptin concentration
Time frame: six months old
blood leptin concentration (ng/ml)
infant blood cortisol concentration
Time frame: six months old
blood cortisol concentration (ug%)
infant saliva cortisol concentration
Time frame: six months old
saliva cortisol (ug%)
infant blood insulin concentration
Time frame: six months old
blood insulin concentration (uU/ml)
infant insulin receptor gene expression in peripheral blood mononuclear cells
Time frame: six months old
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant leptin receptor gene expression in peripheral blood mononuclear cells
Time frame: six months old
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells
Time frame: six months old
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant blood LEAP2 concentration
Time frame: six months old
blood LEAP2 concentration (pg/ml)
infant eating behavior assessed in a Taste acceptance test
Time frame: at 18 month od
Outcome Measures Infant taste acceptance was assessed using two complementary measures: an Ingestion Ratio (IR) and a Liking Ratio (LR). Sweet and fat taste acceptance were evaluated using a lactose solution (0.2 M) and a fat emulsion (3.5% w/v), respectively, with water used as a reference. During each test, infants were sequentially offered bottles containing water and the tastant. Intake volume was determined by weighing bottles before and after ingestion. The IR was calculated as the volume of tastant consumed divided by the total volume of tastant plus water consumed, allowing comparison across infants by accounting for individual differences in sucking behavior. The LR was based on a blinded experimenter's assessment of the infant's overall behavioral response using a standardized 5-point scale ranging from strong rejection to strong acceptance. Both ratios ranged from 0 to 1, with 0.5 indicating indifference relative to water.
11 secondary outcomes
maternal blood leptin concentration
Time frame: 15 days, three and six months postpartum
maternal milk leptin concentration
Time frame: 15 days, three and six months postpartum
maternal blood insulin concentration
Time frame: 15 days, three and six months postpartum
maternal milk insulin concentration
Time frame: 15 days, three and six months postpartum
maternal blood cortisol concentration
Time frame: 15 days, three and six months postpartum
maternal milk cortisol concentration
Time frame: 15 days, three and six months postpartum
maternal insulin receptor gene expression in peripheral blood mononuclear cells
Time frame: 15 days, three and six months postpartum
maternal leptin receptor gene expression in peripheral blood mononuclear cells
Time frame: 15 days, three and six months postpartum
maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells
Time frame: 15 days, three and six months postpartum
maternal blood LEAP2 concentration
Time frame: 15 days, three and six months postpartum
maternal milk LEAP2 concentration
Time frame: 15 days, three and six months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 42823632Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Lopez M, Faquini MS, Castrogiovanni D, Schioth H, Nicklaus S, Perello M, Andreoli MF. Milk and infant plasma hormone concentrations predict sweet and fat taste acceptance and later food intake. J Neuroendocrinol. 2026 Oct;38(10):e70282. doi: 10.1111/jne.70282.
- Derived from this study: PubMed 40450153Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Tournier A, Fasano MV, Andreoli MF. Human milk cortisol is inversely associated with infant BMI and mediates the association between maternal plasma and infant salivary cortisol concentrations. Int J Obes (Lond). 2025 Aug;49(8):1632-1641. doi: 10.1038/s41366-025-01815-4. Epub 2025 May 31.
- Derived from this study: PubMed 39277116Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Lopez M, Tournier A, Castrogiovanni D, Heredia F, Llovera R, Schioth HB, Perello M, Andreoli MF. The Concentration of Liver-Expressed Antimicrobial Peptide 2 in Human Milk and Infant Plasma Is Positively Associated with Adiposity and Body Weight in the First Year of Life. J Nutr. 2024 Nov;154(11):3388-3399. doi: 10.1016/j.tjnut.2024.09.008. Epub 2024 Sep 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria F Andreoli, BsC principal investigator
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity, Infant, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria F Andreoli, PhD (54 221 4535901 ext. 1767, mfandreoli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infant weight (time frame: from birth to 2 years old). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.