NCT05745922

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

February 8, 2023

Last Update Submit

September 25, 2025

Conditions

Breast Milk CollectionOverweight and Obesity

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Breastmilk metabolite composition

    Global metabolomics profiling using MS/MS technology

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

Secondary Outcomes (7)

  • Complex lipids composition

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

  • 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 Growth Factor-1

    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)

  • +2 more secondary outcomes

Other Outcomes (5)

  • Cardiorespiratory fitness

    At baseline

  • Body mass in kg

    At baseline

  • Fat mass in kg

    At baseline

  • +2 more other outcomes

Study Arms (3)

Control

NO INTERVENTION

Resting in seated position

Moderate intensity exercise

EXPERIMENTAL

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

Behavioral: Moderate intensity exercise

High intensity exercise

EXPERIMENTAL

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)

Behavioral: High intensity exercise

Interventions

Moderate intensity exerciseBEHAVIORAL

Treadmill walking/running with moderate intensity

Moderate intensity exercise
High intensity exerciseBEHAVIORAL

Treadmill walking/running with high intensity

High intensity exercise

Eligibility Criteria

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

You may qualify if:

  • weeks postpartum
  • Exclusively breastfeeding
  • Term birth
  • Singleton baby

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of circulation and medical imaging , NTNU

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Breast Milk ExpressionOverweightObesityMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The personnel who will be analysing the milk samples will be blinded to which condition the samples were obtained from and the time-point.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Sequential assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 27, 2023

Study Start

March 1, 2023

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations

NO(1)