Effect of Exercise Training on Breastmilk Composition

NCT ID: NCT05488964

Last Updated: 2025-09-22

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

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2028-03-31

Brief Summary

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The aim of this trial is to investigate whether regular endurance exercise during the lactation period will influence breastmilk composition among individuals with overweight/obesity, and secondarily to assess if such changes impact the growth and health of the infants.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exercise

Regular endurance training for 8 weeks

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Supervised endurance training with moderate-to-high intensity 3-4 times weekly.

Control

Habitual living for 8 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Supervised endurance training with moderate-to-high intensity 3-4 times weekly.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female
* Aged 18 years or older
* Body mass index ≥ 25 kg/m2 pre-pregnancy and/or BMI ≥ 28 kg/m2 postpartum
* Given birth to a singleton term (after 37 weeks + 0 days) baby
* 6-7 weeks postpartum at time of inclusion
* Exclusively breastfeeding the baby (no other foods are given) and intend to continue this practice for ≥ 8 weeks at inclusion
* Understands oral and written Norwegian

Exclusion Criteria

* On-going pregnancy
* Known type 1 or type 2 diabetes
* Known cardiovascular disease
* High intensity exercise more than twice weekly the last three months before inclusion and/or an intention to start regular endurance training within the next 8 weeks at baseline
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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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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Trine Moholdt, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Dept Circulation and Medical Imaging, EXCAR Exercise Lab

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Trine Moholdt, PhD

Role: CONTACT

+4797098594

Facility Contacts

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Trine Moholdt, phd

Role: primary

References

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Moholdt T, Ashby ER, Tommerdal KH, Lemoine MCC, Holm RL, Saetrom P, Iversen AC, Ravi A, Simpson MR, Giskeodegard GF. Randomised controlled trial of exercise training during lactation on breast milk composition in breastfeeding people with overweight/obesity: a study protocol for the MILKSHAKE trial. BMJ Open Sport Exerc Med. 2023 Oct 6;9(4):e001751. doi: 10.1136/bmjsem-2023-001751. eCollection 2023.

Reference Type DERIVED
PMID: 37829712 (View on PubMed)

Other Identifiers

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479236

Identifier Type: -

Identifier Source: org_study_id

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