NCT05042414

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

August 24, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

August 13, 2021

Last Update Submit

October 7, 2022

Conditions

Breastmilk

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Breastmilk metabolite composition

    Metabolomics profiling

    Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

Secondary Outcomes (5)

  • Adiponectin

    Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

  • Leptin

    Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

  • Insulin

    Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

  • Insulin Growth Factor-1

    Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

  • Cytokine profiling (Multiplex 27)

    Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

Other Outcomes (5)

  • Cardiorespiratory fitness

    At baseline

  • Body mass in kg

    At baseline

  • Height in metres

    At baseline

  • +2 more other outcomes

Study Arms (1)

Breastmilk

EXPERIMENTAL

Randomized intervention order.

Behavioral: High intensity interval trainingBehavioral: Moderate intensity trainingBehavioral: Resting

Interventions

High intensity interval trainingBEHAVIORAL

Four times four minutes treadmill interval training

Breastmilk
Moderate intensity trainingBEHAVIORAL

Moderate intensity treadmill training

Breastmilk
RestingBEHAVIORAL

No training

Breastmilk

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 12 weeks postpartum
  • Exclusive breastfeeding
  • Term birth

You may not qualify if:

  • Known cardiovascular disease
  • Type 1 or 2 diabetes mellitus
  • Limited ability to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Circulation and Medical Imaging, NTNU

Trondheim, Norway

Location

Related Publications (2)

  • Lemoine MCC, Klau LJ, Holmen M, Ashby ER, Aachmann FL, Andreassen T, Giskeodegard GF, Moholdt T. Unaltered 3'-sialyllactose and 6'-sialyllactose concentrations in human milk acutely after endurance exercise: a randomized crossover trial. Front Nutr. 2025 Oct 27;12:1638430. doi: 10.3389/fnut.2025.1638430. eCollection 2025.

    PMID: 41220705DERIVED

  • 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.

    PMID: 39981021DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Øystein Risa, Phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

September 13, 2021

Study Start

August 24, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations

NO(1)