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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Milk Collection, Overweight and Obesity

Intervention / Treatment
-----------------
* Behavioral: Moderate intensity exercise
* Behavioral: High intensity exercise


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Sequential assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complex lipids composition | Global metabolomics profiling using MS/MS technology | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) | 
| Adiponectin | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) | 
| Leptin | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) | 
| Insulin Growth Factor-1 | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) | 
| Insulin | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) | 
| Ghrelin | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) | 
| Cytokine profiling (Multiplex 27) | Concentration | Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise