Clinical trial NCT05488964: Effect of Exercise Training on Breastmilk Composition
Official title: Exercised Breastmilk: A Randomised Controlled Trial on the Effect of Exercise Training During Lactation on Breastmilk Composition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this trial is to investigate whether regular endurance exercise during the lactation period will influence breastmilk composition among individuals with overweight/obesity, and secondarily to assess if such changes impact the growth and health of the infants.


Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 years or older
* Body mass index ≥ 25 kg/m2 pre-pregnancy and/or BMI ≥ 28 kg/m2 postpartum
* Given birth to a singleton term (after 37 weeks + 0 days) baby
* 6-7 weeks postpartum at time of inclusion
* Exclusively breastfeeding the baby (no other foods are given) and intend to continue this practice for ≥ 8 weeks at inclusion
* Understands oral and written Norwegian

Exclusion Criteria:

* On-going pregnancy
* Known type 1 or type 2 diabetes
* Known cardiovascular disease
* High intensity exercise more than twice weekly the last three months before inclusion and/or an intention to start regular endurance training within the next 8 weeks at baseline

Primary outcomes:
measure: Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
timeFrame: 0 to 8 weeks
Secondary outcomes:
measure: Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
timeFrame: 0 to 4 weeks
measure: Breastmilk metabolites
timeFrame: 0 to 8 weeks
measure: Breastmilk metabolites
timeFrame: 0 to 4 weeks
measure: Breastmilk microRNA
timeFrame: 0 to 8 weeks
measure: Breastmilk microRNA
timeFrame: 0 to 4 weeks
measure: Maternal insulin sensitivity
timeFrame: 0 to 8 weeks
measure: Maternal fasting circulating insulin C-peptide concentrations
timeFrame: 0 to 8 weeks
measure: Maternal fasting circulating glucose concentrations
timeFrame: After 9 months from baseline
measure: Maternal circulating total cholesterol concentrations
timeFrame: 0 to 8 weeks
measure: Maternal circulating total cholesterol concentrations
timeFrame: After 9 months from baseline
measure: Maternal circulating high-density lipoprotein (HDL) concentrations
timeFrame: 0 to 8 weeks
measure: Maternal circulating high-density lipoprotein (HDL) concentrations
timeFrame: After 9 months from baseline
measure: Maternal circulating low-density lipoprotein (LDL) concentrations
timeFrame: 0 to 8 weeks
measure: Maternal circulating low-density lipoprotein (LDL) concentrations
timeFrame: After 9 months from baseline
measure: Maternal circulating triglycerides concentrations
timeFrame: 0 to 8 weeks
measure: Maternal circulating triglycerides concentrations
timeFrame: After 9 months from baseline
measure: Maternal glycated hemoglobin (HbA1c)
timeFrame: 0 to 8 weeks
measure: Maternal glycated hemoglobin (HbA1c)
timeFrame: After 9 months from baseline
measure: Maternal circulating high-sensitivity c-reactive protein
timeFrame: 0 to 8 weeks
measure: Maternal circulating high-sensitivity c-reactive protein
timeFrame: After 9 months from baseline
measure: Maternal total body mass
timeFrame: 0 to 8 weeks
measure: Maternal total body mass
timeFrame: After 9 months from baseline
measure: Maternal fat mass
timeFrame: 0 to 8 weeks
measure: Maternal fat mass
timeFrame: After 9 months from baseline
measure: Maternal fat-free mass
timeFrame: 0 to 8 weeks
measure: Maternal fat-free mass
timeFrame: After 9 months from baseline
measure: Maternal visceral fat area
timeFrame: 0 to 8 weeks
measure: Maternal visceral fat area
timeFrame: After 9 months from baseline
measure: Maternal bone mass
timeFrame: 0 to 8 weeks
measure: Maternal bone mass
timeFrame: After 9 months from baseline
measure: Maternal waist circumference
timeFrame: 0 to 8 weeks
measure: Maternal waist circumference
timeFrame: After 9 months from baseline
measure: Maternal cardiorespiratory fitness
timeFrame: 0 to 8 weeks
measure: Maternal cardiorespiratory fitness
timeFrame: After 9 months from baseline
measure: Maternal systolic blood pressure
timeFrame: 0 to 8 weeks
measure: Maternal systolic blood pressure
timeFrame: After 9 months from baseline
measure: Maternal diastolic blood pressure
timeFrame: 0 to 8 weeks
measure: Maternal diastolic blood pressure
timeFrame: After 9 months from baseline
measure: Maternal nutrition
timeFrame: 0 to 8 weeks
measure: Maternal physical activity
timeFrame: 0 to 8 weeks
measure: Maternal physical activity
timeFrame: After 9 months from baseline
measure: Maternal physical activity
timeFrame: 0 to 8 weeks
measure: Maternal physical activity
timeFrame: After 9 months from baseline
measure: Maternal psychological well-being
timeFrame: 0 to 8 weeks
measure: Maternal psychological well-being
timeFrame: After 9 months from baseline
measure: Infant total body mass
timeFrame: 0 to 8 weeks
measure: Infant total body mass
timeFrame: After 9 months from baseline
measure: Infant fat mass
timeFrame: 0 to 8 weeks
measure: Infant fat mass
timeFrame: After 9 months from baseline
measure: Infant muscle mass
timeFrame: 0 to 8 weeks
measure: Infant muscle mass
timeFrame: After 9 months from baseline
measure: Infant bone density
timeFrame: 0 to 8 weeks
measure: Infant bone density
timeFrame: After 9 months from baseline
measure: Infant hydration status
timeFrame: 0 to 8 weeks
measure: Infant hydration status
timeFrame: After 9 months from baseline
measure: Infant total body mass (trajectories)
timeFrame: Infant age 4 weeks
measure: Infant length (trajectories)
timeFrame: Infant age 4 weeks
measure: Infant head circumference (trajectories)
timeFrame: Infant age 4 weeks
measure: Infant total body mass (trajectories)
timeFrame: Infant age 6 weeks
measure: Infant length (trajectories)
timeFrame: Infant age 6 weeks
measure: Infant head circumference (trajectories)
timeFrame: Infant age 6 weeks
measure: Infant total body mass (trajectories)
timeFrame: Infant age 3 months
measure: Infant length (trajectories)
timeFrame: Infant age 3 months
measure: Infant head circumference (trajectories)
timeFrame: Infant age 3 months
measure: Infant total body mass (trajectories)
timeFrame: Infant age 6 months
measure: Infant length (trajectories)
timeFrame: Infant age 6 months
measure: Infant head circumference (trajectories)
timeFrame: Infant age 6 months
measure: Infant total body mass (trajectories)
timeFrame: Infant age 8 months
measure: Infant length (trajectories)
timeFrame: Infant age 8 months
measure: Infant head circumference (trajectories)
timeFrame: Infant age 8 months
measure: Infant total body mass (trajectories)
timeFrame: Infant age 10 months
measure: Infant length (trajectories)
timeFrame: Infant age 10 months
measure: Infant head circumference (trajectories)
timeFrame: Infant age 10 months
measure: Infant total body mass (trajectories)
timeFrame: Infant age 12 months
measure: Infant height (trajectories)
timeFrame: Infant age 12 months
measure: Infant head circumference (trajectories)
timeFrame: Infant age 12 months
measure: Infant total body mass (trajectories)
timeFrame: Infant age 24 months
measure: Infant height (trajectories)
timeFrame: Infant age 24 months
measure: Infant head circumference (trajectories)
timeFrame: Infant age 24 months
measure: Infant gut microbiota
timeFrame: 0 to 4 weeks
measure: Infant gut microbiota
timeFrame: 0 to 8 weeks
measure: Infant microRNA
timeFrame: 0 to 8 weeks
Other outcomes:
measure: Exercise adherence
timeFrame: 0 to 8 weeks
measure: Exercise compliance
timeFrame: 0 to 8 weeks
Locations:
city: Trondheim
country: Norway
facility: Dept Circulation and Medical Imaging, EXCAR Exercise Lab
Study officials:
affiliation: Norwegian University of Science and Technology
name: Trine Moholdt, PhD
role: PRINCIPAL_INVESTIGATOR
References: