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

Overweight and Obesity Clinical Trial

— YT  

Official title:

Acute Effects of Endurance Exercise With Moderate and High Intensity on Breast Milk Composition Among Women With Overweight/Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745922
• Other study ID #: 562012
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Norwegian University of Science and Technology
• Contact: Trine Moholdt, Ph.D.
• Phone: 97098594
• Email: trine.moholdt[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Collection
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Moderate intensity exercise
Treadmill walking/running with moderate intensity
• High intensity exercise
Treadmill walking/running with high intensity

Locations

Country	Name	City	State
Norway	Department of circulation and medical imaging , NTNU	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiorespiratory fitness	Peak oxygen uptake	At baseline
Other	Body mass in kg	Impedance scale	At baseline
Other	Fat mass in kg	Impedance scale	At baseline
Other	Muscle mass in kg	Impedance scale	At baseline
Other	Height in metres	Stadiometer	At baseline
Primary	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	Complex lipids composition	Global metabolomics profiling using MS/MS technology	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary	Adiponectin	Concentration	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary	Leptin	Concentration	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary	Insulin Growth Factor-1	Concentration	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary	Insulin	Concentration	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary	Ghrelin	Concentration	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary	Cytokine profiling (Multiplex 27)	Concentration	Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)