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Impact of GLP-1 RAs on Breastmilk Production and Nutritional Composition

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Study Aim

This observational study aims to measure the impact of GLP-1 RAs on your hourly breastmilk production rate and the nutritional composition of your milk, using a standardized expression protocol and the Miris Human Milk Analyzer.

What is being collected

Drug Data

Collected from today forward - Prospective
DrugDNA Samples
Who is being recruted

Behavior+5

+ Body Weight

+ Body Weight Changes

+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2026
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Study ContactJayne F Martin Carli, PhDMore contacts
Last updated: July 22, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on the effects of a specific type of medication, known as GLP-1 Receptor Agonist (GLP-1 RA), on breastmilk production and nutrition in mothers after pregnancy. The interest in using GLP-1 RA medications post-pregnancy is growing, and this study aims to understand if these medications impact the quantity or quality of breastmilk. The study is particularly interested in exploring how weight loss induced by GLP-1 RA affects breastmilk production and its nutritional composition, including milk fat content. This research is important as it can provide valuable insights into the safety and effectiveness of GLP-1 RA medications for breastfeeding mothers. Participants in this study will be asked to weigh themselves daily and report their measurements. Over a period of approximately 2.5 to 4.5 months, they will attend 2-3 morning study visits, each lasting about 3 to 3.5 hours. During these visits, participants will use a provided breastpump to express milk for measurement of hourly milk production. They will also provide a small amount of milk for further analysis. The study will assess milk production rates before and after mothers start taking injected GLP-1 RA medications to reduce their body weight. Weight loss will be confirmed using 7-day body weight averages. The primary outcomes of the study include the hourly milk production rate and the milk's macronutrient composition, which will be evaluated using a standardized milk expression protocol and the Miris Human Milk Analyzer, respectively.

Principal SponsorUniversity of Colorado, Denver
Study ContactJayne F Martin Carli, PhDMore contacts
Last updated: July 22, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBody WeightBody Weight ChangesFeeding BehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsBreast FeedingWeight Loss

Criteria

7 inclusion criteria required to participate
Breastfeeding mothers of single or multiple infants

Access to a breastpump, if needed for maintaining breastfeeding behaviors

Willingness to track and report body weight daily

Eligible for a GLP-1 RA administered subcutaneously (oral GLP-1 RAs contain absorption enhancers, which may drive accumulation in milk)

Show More Criteria

2 exclusion criteria prevent from participating
Currently taking GLP-1 RA medication or other weight loss medication

Induced lactation, due to unknowns regarding the durability of the mammary gland's milk production after exogenous stimulation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Colorado Anschutz School of Medicine

Aurora, United StatesOpen University of Colorado Anschutz School of Medicine in Google Maps
Recruiting
One Study Center