Impact of GLP-1 RAs on Breastmilk Production and Nutritional Composition
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.
Drug Data
Collected from today forward - ProspectiveBehavior+5
+ Body Weight
+ Body Weight Changes
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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
University of Colorado Anschutz School of Medicine
Aurora, United StatesOpen University of Colorado Anschutz School of Medicine in Google Maps