ExMilk: Acute Effects of Endurance Exercise on Breastmilk Composition

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05042414
• Collaborator: St. Olavs Hospital (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Breastmilk	Behavioral: High intensity interval training; Behavioral: Moderate intensity training; Behavioral: Resting	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Acute Effects of Endurance Exercise on Breastmilk Composition: Pilot Study
• Actual Study Start Date: Aug 24, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Breastmilk Randomized intervention order.	Behavioral: High intensity interval training; Four times four minutes treadmill interval training; Behavioral: Moderate intensity training; Moderate intensity treadmill training; Behavioral: Resting; No training

Outcome Measures

Primary Outcome Measures

1. Breastmilk metabolite composition [Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)]

   Metabolomics profiling

Secondary Outcome Measures

1. Adiponectin [Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)]

   Concentration in breastmilk

2. Leptin [Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)]

   Concentration in breastmilk

3. Insulin [Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)]

   Concentration in breastmilk

4. Insulin Growth Factor-1 [Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)]

   Concentration in breastmilk

5. Cytokine profiling (Multiplex 27) [Change from before exercise to after exercise (+0 hour, +1 hour, and + 4 hours)]

   Concentration in breastmilk

Other Outcome Measures

1. Cardiorespiratory fitness [At baseline]

   Peak oxygen uptake

2. Body mass in kg [At baseline]

   Impedance scale

3. Height in metres [At baseline]

   stadiometer

4. Fat mass in kg [At baseline]

   Impedance scale

5. Muscle mass in kg [At baseline]

   Impedance scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Circulation and Medical Imaging, NTNU	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• St. Olavs Hospital

Investigators

• Study Director: Øystein Risa, Phd, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT05042414
• Other Study ID Numbers: 263493
• First Posted: Sep 13, 2021
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Exercise

Study Results

No Results Posted as of Sep 13, 2021