Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity

NCT ID: NCT05745922

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-05-20

Brief Summary

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The investigators will determine the acute effect of exercise on breastmilk composition. Participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. The conditions will be randomly allocated to each participant. Breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. Dietary intake will be standardized on the test days.

Detailed Description

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Conditions

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Breast Milk Collection Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Sequential assignment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
The personnel who will be analysing the milk samples will be blinded to which condition the samples were obtained from and the time-point.

Study Groups

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Control

Resting in seated position

Group Type NO_INTERVENTION

No interventions assigned to this group

Moderate intensity exercise

Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes

Group Type EXPERIMENTAL

Moderate intensity exercise

Intervention Type BEHAVIORAL

Treadmill walking/running with moderate intensity

High intensity exercise

High intensity interval training: treadmill walking/running. 10 minutes warm-up at 70% of heart rate maximum, followed by four 4-minutes bouts at 90-95% of heart rate maximum, separated by 3-minutes active recovery (at 70% of heart rate maximum)

Group Type EXPERIMENTAL

High intensity exercise

Intervention Type BEHAVIORAL

Treadmill walking/running with high intensity

Interventions

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Moderate intensity exercise

Treadmill walking/running with moderate intensity

Intervention Type BEHAVIORAL

High intensity exercise

Treadmill walking/running with high intensity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 6 weeks postpartum
* Exclusively breastfeeding
* Term birth
* Singleton baby

Exclusion Criteria

* Known cardiovascular disease
* Known type 1 or type 2 diabetes
* Limited ability to exercise
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of circulation and medical imaging , NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Partner

View Document

Document Type: Informed Consent Form: Participant (mother)

View Document

Other Identifiers

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562012

Identifier Type: -

Identifier Source: org_study_id

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