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NCT07036640 · ClinicalTrials.gov registry record · NA

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

A NA study of Lactation, sponsored by Providence College.

Recruiting
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT07036640: Recruiting NA study of Lactation, sponsored by Providence College.

NCT07036640 is a NA study of Lactation that is actively recruiting participants, run by Providence College. The registered enrollment target is 10 participants, below the 87-participant average among 4 other Lactation trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07036640, a NA study of Lactation, is actively recruiting participants, sponsored by Providence College.

RECRUITING
Registry status
NA
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

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

Primary Outcome

Breastmilk lipid, protein, and lactose content

Conditions Studied

Interventions

  • OTHER Heat exposure

Study Locations (1)

Rhode Island

  • Providence College - Providence

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2025-07-10
Est. Completion 2026-05-01
Phase NA
Providence College

2 total trials

What NCT07036640 shows while recruiting

NCT07036640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 87-participant average among 4 other Lactation trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Lactation appearing as the primary indexed condition, and to 1 intervention - of which Heat exposure is the first listed.

NCT07036640 reports a single indexed study location in Rhode Island.

Frequently Asked Questions

What is clinical trial NCT07036640 about?

NCT07036640 is a clinical study titled "The Impact of Acute Exercise in the Heat on Breast Milk Production and Composition in Lactating Women". 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 e...

What is the current status of trial NCT07036640?

This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2025-07-10. Estimated completion is 2026-05-01.

What conditions does trial NCT07036640 study?

This clinical trial studies the following conditions: Lactation.

What interventions are being tested in trial NCT07036640?

The interventions under investigation include: Heat exposure (OTHER).

Who is sponsoring clinical trial NCT07036640?

This trial is sponsored by Providence College, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07036640 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT07036640, the US trial registry maintained by the National Library of Medicine. NCT07036640 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.