Acute Effects of Endurance Exercise on Breastmilk Composi... | NCT05042414

Studies
Acute Effects of Endurance Exercise on Breastmilk Composition

NCT05042414

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Oct 10, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Breastmilk

Interventions

High intensity interval training
Moderate intensity training
Resting

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2021Actual

Primary Completion Date

Jun 1, 2022Actual

Completion Date

Jun 1, 2022Actual

First Submitted Date

Aug 13, 2021

First Submission Date that Met QC Criteria

Sep 4, 2021

First Posted Date

Sep 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2022

Last Update Posted Date

Oct 10, 2022Actual

Name	Class
St. Olavs Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breastmilk	Experimental	Randomized intervention order.	Behavioral: High intensity interval training Behavioral: Moderate intensity training Behavioral: Resting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High intensity interval training	Behavioral	Four times four minutes treadmill interval training	Breastmilk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breastmilk metabolite composition	Metabolomics profiling	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)

Secondary Outcomes

Measure	Description	Time Frame
Adiponectin	Concentration in breastmilk	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Leptin	Concentration in breastmilk

Other Outcomes

Measure	Description	Time Frame
Cardiorespiratory fitness	Peak oxygen uptake	At baseline
Body mass in kg	Impedance scale	At baseline

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Øystein Risa, Phd	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Circulation and Medical Imaging, NTNU		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41220705	Derived	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.
39981021

ID	Term
D064797	Physical Conditioning, Human
D015444	Exercise
D009043	Motor Activity
D009068	Movement