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

Primary Purpose

Breast Milk Collection, Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Moderate intensity exercise
High intensity exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Milk Collection focused on measuring Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of circulation and medical imaging , NTNURecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Moderate intensity exercise

High intensity exercise

Arm Description

Resting in seated position

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

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)

Outcomes

Primary Outcome Measures

Breastmilk metabolite composition
Global metabolomics profiling using MS/MS technology

Secondary Outcome Measures

Complex lipids composition
Global metabolomics profiling using MS/MS technology
Adiponectin
Concentration
Leptin
Concentration
Insulin Growth Factor-1
Concentration
Insulin
Concentration
Ghrelin
Concentration
Cytokine profiling (Multiplex 27)
Concentration

Full Information

First Posted
February 8, 2023
Last Updated
March 1, 2023
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05745922
Brief Title
Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity
Acronym
YT
Official Title
Acute Effects of Endurance Exercise With Moderate and High Intensity on Breast Milk Composition Among Women With Overweight/Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Milk Collection, Overweight and Obesity
Keywords
Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Sequential assignment
Masking
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.
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Resting in seated position
Arm Title
Moderate intensity exercise
Arm Type
Experimental
Arm Description
Moderate intensity endurance exercise, treadmill walking/running at 70% of heart rate maximum for 40 minutes
Arm Title
High intensity exercise
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity exercise
Intervention Description
Treadmill walking/running with moderate intensity
Intervention Type
Behavioral
Intervention Name(s)
High intensity exercise
Intervention Description
Treadmill walking/running with high intensity
Primary Outcome Measure Information:
Title
Breastmilk metabolite composition
Description
Global metabolomics profiling using MS/MS technology
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary Outcome Measure Information:
Title
Complex lipids composition
Description
Global metabolomics profiling using MS/MS technology
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Title
Adiponectin
Description
Concentration
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Title
Leptin
Description
Concentration
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Title
Insulin Growth Factor-1
Description
Concentration
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Title
Insulin
Description
Concentration
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Title
Ghrelin
Description
Concentration
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Title
Cytokine profiling (Multiplex 27)
Description
Concentration
Time Frame
Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Other Pre-specified Outcome Measures:
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake
Time Frame
At baseline
Title
Body mass in kg
Description
Impedance scale
Time Frame
At baseline
Title
Fat mass in kg
Description
Impedance scale
Time Frame
At baseline
Title
Muscle mass in kg
Description
Impedance scale
Time Frame
At baseline
Title
Height in metres
Description
Stadiometer
Time Frame
At baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trine Moholdt, Ph.D.
Phone
97098594
Ext
+47
Email
trine.moholdt@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Øivind Rognmo, Ph.D.
Phone
90133775
Ext
+47
Email
oivind.rognmo@ntnu.no
Facility Information:
Facility Name
Department of circulation and medical imaging , NTNU
City
Trondheim
ZIP/Postal Code
7491
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, phd
Phone
0047 97098594
Email
trine.moholdt@ntnu.no

12. IPD Sharing Statement

Learn more about this trial

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

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