CompletedNot Applicable

The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development

United States221 participantsStarted 2016-07

Plain-language summary

This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains certain natural sugars that can promote the growth of 'good' bacteria in the intestines and reduce the growth of harmful bacteria. The purpose of this study is to look at the effects of these natural sugars in breast milk on the infant's bacteria and the impact of this on development of obesity and cognitive outcomes by 2 years of age with plans for longer term follow up contingent upon funding.

Who can participate

Age range

18 Years – 59 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Mothers who self-identify as Hispanic * Mothers who have or have had singleton births * Mothers will be recruited prior to their infant's birth or up to 1-month postpartum * Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level Exclusion Criteria: * Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers * Physical, mental, or cognitive issues that prevent participation * Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles * Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs * Clinical diagnosis of gestational diabetes * Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities * Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infant weight z-scores at baseline

Timeframe: Baseline

Infant weight z-scores at 6 months

Timeframe: 6 months

Infant weight z-scores at 12 months

Timeframe: 12 months

Infant weight z-scores at 18 months

Timeframe: 18 months

Infant weight z-scores at 24 months

Timeframe: 24 months

Infant weight z-scores at 36 months

Timeframe: 36 months

Infant skinfold thickness at baseline

Timeframe: Baseline

Infant skinfold thickness at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT04434027

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range

18 Years – 59 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Infant weight z-scores at baseline

Timeframe: Baseline

Infant weight z-scores at 6 months

Timeframe: 6 months

Infant weight z-scores at 12 months

Timeframe: 12 months

Infant weight z-scores at 18 months

Timeframe: 18 months

Infant weight z-scores at 24 months

Timeframe: 24 months

Infant weight z-scores at 36 months

Timeframe: 36 months

Infant skinfold thickness at baseline

Timeframe: Baseline

Infant skinfold thickness at 6 months

Timeframe: 6 months