Acute Effects of Endurance Exercise on Breastmilk Composition

Breastmilk Clinical Trial

— ExMilk  

Official title:

Acute Effects of Endurance Exercise on Breastmilk Composition: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042414
• Other study ID #: 263493
• Status: Completed
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastmilk

Intervention

Behavioral:
• High intensity interval training
Four times four minutes treadmill interval training
• Moderate intensity training
Moderate intensity treadmill training
• Resting
No training

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	Height in metres	stadiometer	At baseline
Other	Fat mass in kg	Impedance scale	At baseline
Other	Muscle mass in kg	Impedance scale	At baseline
Primary	Breastmilk metabolite composition	Metabolomics profiling	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Secondary	Adiponectin	Concentration in breastmilk	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Secondary	Leptin	Concentration in breastmilk	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Secondary	Insulin	Concentration in breastmilk	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Secondary	Insulin Growth Factor-1	Concentration in breastmilk	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)
Secondary	Cytokine profiling (Multiplex 27)	Concentration in breastmilk	Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)