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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Recruiting

CT.gov ID

NCT05745922

Collaborator

St. Olavs Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Milk Collection Overweight and Obesity	Behavioral: Moderate intensity exercise Behavioral: High intensity exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Sequential assignmentSequential assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The personnel who will be analysing the milk samples will be blinded to which condition the samples were obtained from and the time-point.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Resting in seated position
Experimental: Moderate intensity exercise Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes	Behavioral: Moderate intensity exercise Treadmill walking/running with moderate intensity
Experimental: 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)	Behavioral: High intensity exercise Treadmill walking/running with high intensity

Arm

Intervention/Treatment

No Intervention: Control

Resting in seated position

Experimental: Moderate intensity exercise

Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes

Behavioral: Moderate intensity exercise

Treadmill walking/running with moderate intensity

Experimental: 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)

Behavioral: High intensity exercise

Treadmill walking/running with high intensity

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Cardiorespiratory fitness [At baseline]
Peak oxygen uptake
Body mass in kg [At baseline]
Impedance scale
Fat mass in kg [At baseline]
Impedance scale
Muscle mass in kg [At baseline]
Impedance scale
Height in metres [At baseline]
Stadiometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of circulation and medical imaging , NTNU	Trondheim		Norway	7491

Sponsors and Collaborators

Norwegian University of Science and Technology
St. Olavs Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT05745922

Other Study ID Numbers:

562012

First Posted:

Feb 27, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Norwegian University of Science and Technology

Exercise

Additional relevant MeSH terms:

Obesity

Overweight

Study Results

No Results Posted as of Mar 2, 2023