RECRUITING

The Impact of Acute Exercise in the Heat on Breast Milk Production and Composition in Lactating Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial aims to determine whether heat stress alters 24-hour breast milk production and composition following an acute bout of exercise in the heat among lactating women. The main questions are: 1. To ascertain whether heat stress alters 24-hour breast milk production following acute exercise in the heat among lactating women. We hypothesize that breast milk production will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Lactating mothers will complete an acute exercise bout at 40% of their peak oxygen consumption (VO2peak) for 60 mins in a hot (36 °C, 40% relative humidity) and thermoneutral environment (20 °C, 20% relative humidity). Participants will record their total breast milk production in a 24-hour period using an infant scale. 2. to discover whether heat stress impacts the energy composition of breast milk following acute exercise in the heat among lactating women. We hypothesize that energy density will decrease to a greater extent following acute exercise in the heat compared to acute exercise with no heat stress. Participants will use a manual expression breast pump to collect 10 mL of breast milk from each breast immediately and 24 hours post-exercise. Energy density (lactose, protein, and lipid content) will be assessed via enzyme-linked immunosorbent assays. Participants will complete the following visits: 1) initial consent visit 2) baseline testing; 3) acute exercise in the hot condition (HOT; 36C, 40% relative humidity), and 4) acute exercise in the temperate, thermoneutral condition (TEMP; 20C, 20% relative humidity). The baseline testing day will measure participant anthropometrics including height, weight, and body composition measured by a DEXA scan. For both experimental trials, participants will be asked to walk on a treadmill at based on their metabolic heat production (8W/kg) for 60 minutes. Heart rate (HR), mean skin temperature (Tsk), core temperature (Tcore), sweat loss (SL), and fluid intake will be measured throughout the exercise protocol. Breast milk composition will be measured through milk expression using a manual expression breast pump immediately and 24 hours post-exercise. Participants will log their breast milk production for 24 hours following the exercise using an infant scale to measure their infants before and after each feed.

Official Title

The Impact of Acute Exercise in the Heat on Breast Milk Production and Composition in Lactating Women

Quick Facts

Study Start:2025-07-10
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07036640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently breastfeeding or pumping expressed breastmilk for their 6-week to 24-month infants
  2. * Aged 18-45 years old
  3. * Delivered their infants between 37-42 weeks of gestational age
  1. * Obsterical complications during pregnancy
  2. * multiple gestation
  3. * Chronic disease (i.e., diabetes, hypertension, metabolic disease)
  4. * Heat illnness in the last 3 month

Contacts and Locations

Study Contact

Margaret C Morrissey-Basler, PhD
CONTACT
4018650219
mmorri17@providence.edu

Principal Investigator

Margaret C Morrissey-Basler, PhD
PRINCIPAL_INVESTIGATOR
Providence College

Study Locations (Sites)

Providence College
Providence, Rhode Island, 02918
United States

Collaborators and Investigators

Sponsor: Providence College

  • Margaret C Morrissey-Basler, PhD, PRINCIPAL_INVESTIGATOR, Providence College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-10
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2025-07-10
Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

  • Lactation
  • Exercise
  • Heat Stress

Additional Relevant MeSH Terms

  • Lactation