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Does a Mother's weight change the chemistry of her breast milk?

NCT ID NCT03301753

Knowledge-focused Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers are studying whether a mother's weight and blood sugar during pregnancy affect the makeup of her breast milk, and whether those differences influence how her baby grows. The study will follow pregnant women with a range of body sizes, including those with gestational diabetes, and analyze milk samples for hormones and other compounds. The goal is to understand if breast milk composition helps explain why babies of mothers with obesity face a higher risk of later obesity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the link is confirmed, this could guide new ways to support breastfeeding mothers with obesity or gestational diabetes, potentially reducing the risk of obesity in their children.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Many factors influence infant growth, and the findings may not apply to all mothers or babies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,050 people

The number who actually took part.

Started

Jul 2014

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

(Minneapolis site): In the Twin Cities metro area, subjects will be recruited from patients who attend medical group clinics for Ob/Gyn care in their second trimester of pregnancy through the various means, including through the OB/GYN department of the University of Minneosta Medical School via letter and follow-up phone call for final screening. (Oklahoma City site): Recruitment in the OKC metro area will be through OUHSC Ob/Gyn clinic, and local private practice OB/GYN clinics during the second trimester, through the La Leche League, and public announcements.

Ages

0 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant females * 21 to 45 years of age at the time of delivery * Pre-gravid BMI between 18.5 to 40 kg/m2 * Healthy pregnancy defined as \<3 days in hospital following delivery * Report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3-months * If parity \>1, report that they successfully breast fed a previous pregnancy for at least 3 months * Singleton gestation * Term pregnancy (gestational age \>37 but \<42 weeks) * Infant birth weight \>2,500 grams but \<4,500 grams. Exclusion Criteria: * Alcohol consumption \>1 drink per week during pregnancy/lactation * Tobacco consumption during pregnancy/lactation * History/current Type I or II diabetes * Inability to speak/understand English * Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth

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Conditions

The condition(s) this trial relates to.

Breast Milk Expression gestational diabetes Infant Nutrition Disorders Obesity obesity disorder overnutrition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breastmilk collection Gestational diabetes mellitus (GDM) Infant overnutrition Obesity Pregnancy

Contacts and locations

Locations

  • University of Minnesota School of Public Health

    Minneapolis, Minnesota, 55454, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

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