Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity; Breast Milk Collection
• Interventions: Behavioral: High intensity exercise; Behavioral: Moderate intensity exercise

• Registration Number: NCT05745922
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-27
• Study Start: 2023-03-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-20
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High intensity exercise	High intensity exercise	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)
Moderate intensity exercise	Moderate intensity exercise	Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes

Primary Outcome Measures

Name	Time	Method
Breastmilk metabolite composition	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Global metabolomics profiling using MS/MS technology

Secondary Outcome Measures

Name	Time	Method
Ghrelin	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Concentration
Leptin	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Concentration
Insulin Growth Factor-1	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Concentration
Complex lipids composition	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Global metabolomics profiling using MS/MS technology
Adiponectin	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Concentration
Insulin	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Concentration
Cytokine profiling (Multiplex 27)	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)	Concentration

Trial Locations

Locations (1)

Department of circulation and medical imaging , NTNU; 🇳🇴 Trondheim, Norway