跳至主要内容
临床试验/NCT07036640
NCT07036640招募中不适用

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

Providence College1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Breastmilk Composition

研究概览

简要总结

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.

详细描述

This study will be a randomized, cross-over design with four study visits: 1) an initial visit where the participant can see the study equipment, ask questions, and fill out a brief questionnaire to determine whether they are eligible to participant; 2) baseline and metabolic heat production testing; 3) acute exercise in the hot condition [experimental trial 1 (HOT): 36C, 40% relative humidity], and 4) acute exercise in the temperate, thermoneutral condition [experimental trial 2 (TEMP): 20C, 20% relative humidity]. Data collection will occur at the Health and Human Performance Laboratory (HHPL) in the Department of Health Sciences.

Visit 1: Initial Visit The participant will come to the lab for an initial visit. During this brief visit (<30 min), the participant can ask questions about the study, see the study equipment, and will be asked to complete a questionnaire to determine their eligibility.

Visit 2 (Baseline and Metabolic Heat Production Testing):

The baseline testing will collect participant anthropometric data, which includes height, body mass, and body composition (dual-energy X-ray absorptiometry, DXA) scan and a stepwise metabolic heat production test. Participants will report to the laboratory having abstained from caffeine, alcohol, and food (12, 24, and 4 hours, respectively). Upon arrival, participants will provide a small urine sample in a sterile urine cup to measure hydration status and for a pregnancy test. Researchers will measure hydration status using a refractometer. If the pregnancy test is positive, the PI will inform the participant that the test is positive and will not perform the scan. The participant will also no longer be eligible to continue with the study. After hydration assessment, nude body mass and height will be collected and the participant's body composition will measured using DXA. To obtain a nude body mass, a private curtain-changing area with a body weight scale will be provided to ensure privacy. Only the participant will be able to enter. The scale reading will come outside the private curtain area for the researchers to see. The DXA software will generate lean mass, fat mass, and body fat percentage. To calculate exercise intensity based on a fixed metabolic heat production (per unit body mass), participants will undergo a 24-min incremental treadmill test in an environmental chamber. Participants will perform the test in the same environmental conditions as the HOT trial (36C, 40% relative humidity; described below). Participants will don a heart rate (HR) monitor before testing. The treadmill test will consist of 6 x 4-min stages and progressively increase speed (2.5mph, 3.0mph, 3.5mph, 4.0mph, 4.5mph, and 5.0mph). The treadmill grade will be set at 2% to account for terrain and wind resistance. Oxygen consumption and respiratory exchange were collected continuously (30-sec average) using a Hans Rudolph metabolic mask (Hans Rudolph Inc., Shawnee, KS, USA) attached to a hose and delivered to the metabolic cart system (Parvo Medics Truemax 2400 Metabolic Measurement System, Consentius Technologies, Sandy, UT). These variables will be used to calculate metabolic heat production using partitional calorimetry (Cramer & Jay, 2019). An exercise intensity of 8 W/kg was selected to elicit a brisk walking intensity. The metabolic heat production test is a standard procedure used in the thermal physiology literature to perform an unbiased comparison of thermoregulatory responses between groups (Jay & Cramer 2015).

Visit 3 and 4: Experimental Trials (HOT & TEMP). Experimental trials (HOT and TEMP) will consist of a 60 min treadmill exercise protocol at a fixed metabolic heat production per unit body mass (8 W/kg). Exercise will be performed in an environmental chamber. HR, mean skin temperature (Tsk), core temperature (Tcore), sweat loss, 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 24-hour before (post exercise), one hour-post exercise and 24 hours post-exercise. Breastmilk samples will not be collected at the laboratory. Participants will be asked to collect samples at home and will be provided written instructions on the breastmilk collection procedure (described below). Participants will log their breast milk production for 24 hours before and after the exercise protocol using a supplied infant scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •Obsterical complications during pregnancy
  • •multiple gestation
  • •Chronic disease (i.e., diabetes, hypertension, metabolic disease)
  • •Heat illnness in the last 3 month

研究组 & 干预措施

Heat exposure

Experimental

Heat exposure in environmental chamber during exercise (60 mins)

干预措施: Heat exposure (Other)

Thermoneutral Condition

No Intervention

Thermoneutral temperature (non-heat exposure condition)

结局指标

主要结局

Breastmilk Composition

时间窗: Measured 24hr before exercise, one hour post-exercise, and 24hr post exercise for each condition

Breastmilk lipid, protein, and lactose content

Breastmilk Production

时间窗: Collected 24-hour before exercise, 1-hour post-exercise, and 24-hour post-exercise

Breastmilk production (lactation)

次要结局

  • Core temperature(Collected every minute for 60 minutes during exercise)
  • Heart rate(Collected every minute for 60 minutes during exercise)
  • Skin temperature(Collected every minute for 60 min during exercise)

研究者

发起方
Providence College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Morrissey

Assistant Professor

Providence College

研究点 (1)

Loading locations...

相似试验