Acute Effects of Endurance Exercise on Breastmilk Composition

NCT ID: NCT05042414

Last Updated: 2022-10-10

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-24

Study Completion Date

2022-06-01

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. At the time of study commencement, the trial (including planned analyses) is not fully funded. Additional milk will be stored for future analyses (not yet specified) when funding is secured.

Detailed Description

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Conditions

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Breastmilk

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Breastmilk

Randomized intervention order.

Group Type EXPERIMENTAL

High intensity interval training

Intervention Type BEHAVIORAL

Four times four minutes treadmill interval training

Moderate intensity training

Intervention Type BEHAVIORAL

Moderate intensity treadmill training

Resting

Intervention Type BEHAVIORAL

No training

Interventions

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High intensity interval training

Four times four minutes treadmill interval training

Intervention Type BEHAVIORAL

Moderate intensity training

Moderate intensity treadmill training

Intervention Type BEHAVIORAL

Resting

No training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 6 to 12 weeks postpartum
* Exclusive breastfeeding
* Term birth

Exclusion Criteria

* Known cardiovascular disease
* Type 1 or 2 diabetes mellitus
* 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

Principal Investigators

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Øystein Risa, Phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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Department of Circulation and Medical Imaging, NTNU

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Holm RL, Holmen M, Sujan MAJ, Giskeodegard GF, Moholdt T. Acute effect of endurance exercise on human milk insulin concentrations: a randomised cross-over study. Front Nutr. 2025 Jan 27;11:1507156. doi: 10.3389/fnut.2024.1507156. eCollection 2024.

Reference Type DERIVED
PMID: 39981021 (View on PubMed)

Other Identifiers

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263493

Identifier Type: -

Identifier Source: org_study_id

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