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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05745922
Other study ID # 562012
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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