The Impact of Acute Exercise in the Heat on Breast Milk Production and Composition in Lactating Women
Providence College · NCT07036640
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Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–45 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 10
- US sites recruiting
- 1
- Study start
- July 10, 2025
- Record last updated
- June 25, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
- 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.
- 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.
Being studied: Heat exposure
Conditions: Lactation
Eligibility criteria
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Show full criteria
Inclusion Criteria
- Currently breastfeeding or pumping expressed breastmilk for their 6-week to 24-month infants
- Aged 18-45 years old
- Delivered their infants between 37-42 weeks of gestational age
Exclusion Criteria
- Obsterical complications during pregnancy
- multiple gestation
- Chronic disease (i.e., diabetes, hypertension, metabolic disease)
- Heat illnness in the last 3 month
Recruiting US locations
Providence College
Providence, RI 02918
Site contact: Margaret C Morrissey-Basler, PhD · 4018650219 · mmorri17@providence.edu
Study contacts (from the official record)
- Margaret C Morrissey-Basler, PhD · 4018650219 · mmorri17@providence.edu