Effect of Exercise Training on Breastmilk Composition

NCT05488964 | Active Not Recruiting

• 1 other identifier: 479236
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)

  Relative concentration of 3'SL in breastmilk

  0 to 8 weeks

Secondary Outcomes (82)

• Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)

  0 to 4 weeks

• Breastmilk metabolites

  0 to 8 weeks

• Breastmilk metabolites

  0 to 4 weeks

• Breastmilk microRNA

  0 to 8 weeks

• Breastmilk microRNA

  0 to 4 weeks

Other Outcomes (2)

• Exercise adherence

  0 to 8 weeks

• Exercise compliance

  0 to 8 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

Regular endurance training for 8 weeks

Behavioral: Exercise

Control

NO INTERVENTION

Habitual living for 8 weeks

Interventions

Exercise BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Understands oral and written Norwegian

You may not qualify if:

• On-going pregnancy
• Known type 1 or type 2 diabetes
• Known cardiovascular disease

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Dept Circulation and Medical Imaging, EXCAR Exercise Lab

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 37829712 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Trine Moholdt, PhD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 5, 2022
• Study Start: September 1, 2022
• Primary Completion: November 24, 2025
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: IPD will be shared upon requests from researchers. The principal investigator (Trine Moholdt) will review requests.

Locations

NO (1)