Exercised Breastmilk: A Randomised Controlled Trial on the Effect of Exercise Training During Lactation on Breastmilk Composition

Norwegian University of Science and Technology2 个研究点分布在 1 个国家目标入组 62 人2022年9月1日

适应症Obesity

干预措施Exercise

概览

阶段: 不适用
干预措施: Exercise
疾病 / 适应症: Obesity
发起方: Norwegian University of Science and Technology
入组人数: 62
试验地点: 2
主要终点: Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
状态: 进行中（未招募）
最后更新: 24天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2022年9月1日

结束日期

2028年3月1日

最后更新

24天前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

Norwegian University of Science and Technology

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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

研究组 & 干预措施

Exercise

Regular endurance training for 8 weeks

干预措施: Exercise

Control

Habitual living for 8 weeks

结局指标

主要结局

Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)

时间窗: 0 to 8 weeks

Relative concentration of 3'SL in breastmilk

次要结局

Infant microRNA(0 to 8 weeks)
Maternal systolic blood pressure(After 9 months from baseline)
Maternal diastolic blood pressure(After 9 months from baseline)
Infant muscle mass(After 9 months from baseline)
Maternal insulin sensitivity(0 to 8 weeks)
Maternal fasting circulating insulin C-peptide concentrations(0 to 8 weeks)
Maternal circulating total cholesterol concentrations(After 9 months from baseline)
Maternal fat-free mass(After 9 months from baseline)
Maternal cardiorespiratory fitness(After 9 months from baseline)
Infant fat mass(After 9 months from baseline)
Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)(0 to 4 weeks)
Breastmilk microRNA(0 to 4 weeks)
Maternal fasting circulating glucose concentrations(After 9 months from baseline)
Maternal visceral fat area(After 9 months from baseline)
Breastmilk metabolites(0 to 4 weeks)
Maternal circulating high-sensitivity c-reactive protein(After 9 months from baseline)
Maternal bone mass(After 9 months from baseline)
Infant total body mass (trajectories)(Infant age 24 months)
Maternal circulating high-density lipoprotein (HDL) concentrations(After 9 months from baseline)
Maternal circulating triglycerides concentrations(After 9 months from baseline)
Maternal fat mass(After 9 months from baseline)
Infant total body mass(After 9 months from baseline)
Infant hydration status(After 9 months from baseline)
Infant length (trajectories)(Infant age 10 months)
Maternal circulating low-density lipoprotein (LDL) concentrations(After 9 months from baseline)
Maternal glycated hemoglobin (HbA1c)(After 9 months from baseline)
Maternal total body mass(After 9 months from baseline)
Maternal waist circumference(After 9 months from baseline)
Maternal nutrition(0 to 8 weeks)
Maternal psychological well-being(After 9 months from baseline)
Infant bone density(After 9 months from baseline)
Infant head circumference (trajectories)(Infant age 24 months)
Infant height (trajectories)(Infant age 24 months)
Infant gut microbiota(0 to 8 weeks)
Maternal physical activity(After 9 months from baseline)
Breastmilk metabolites(0 to 8 weeks)
Breastmilk microRNA(0 to 8 weeks)
Maternal circulating total cholesterol concentrations(0 to 8 weeks)
Maternal circulating high-density lipoprotein (HDL) concentrations(0 to 8 weeks)
Maternal circulating low-density lipoprotein (LDL) concentrations(0 to 8 weeks)
Maternal circulating triglycerides concentrations(0 to 8 weeks)
Maternal glycated hemoglobin (HbA1c)(0 to 8 weeks)
Maternal circulating high-sensitivity c-reactive protein(0 to 8 weeks)
Maternal total body mass(0 to 8 weeks)
Maternal fat mass(0 to 8 weeks)
Maternal fat-free mass(0 to 8 weeks)
Maternal visceral fat area(0 to 8 weeks)
Maternal bone mass(0 to 8 weeks)
Maternal waist circumference(0 to 8 weeks)
Maternal cardiorespiratory fitness(0 to 8 weeks)
Maternal systolic blood pressure(0 to 8 weeks)
Maternal diastolic blood pressure(0 to 8 weeks)
Maternal physical activity(0 to 8 weeks)
Maternal psychological well-being(0 to 8 weeks)
Infant total body mass(0 to 8 weeks)
Infant fat mass(0 to 8 weeks)
Infant muscle mass(0 to 8 weeks)
Infant bone density(0 to 8 weeks)
Infant hydration status(0 to 8 weeks)
Infant total body mass (trajectories)(Infant age 4 weeks)
Infant length (trajectories)(Infant age 4 weeks)
Infant head circumference (trajectories)(Infant age 4 weeks)
Infant total body mass (trajectories)(Infant age 6 weeks)
Infant length (trajectories)(Infant age 6 weeks)
Infant head circumference (trajectories)(Infant age 6 weeks)
Infant total body mass (trajectories)(Infant age 3 months)
Infant length (trajectories)(Infant age 3 months)
Infant head circumference (trajectories)(Infant age 3 months)
Infant total body mass (trajectories)(Infant age 6 months)
Infant length (trajectories)(Infant age 6 months)
Infant head circumference (trajectories)(Infant age 6 months)
Infant total body mass (trajectories)(Infant age 8 months)
Infant length (trajectories)(Infant age 8 months)
Infant head circumference (trajectories)(Infant age 8 months)
Infant total body mass (trajectories)(Infant age 10 months)
Infant head circumference (trajectories)(Infant age 10 months)
Infant total body mass (trajectories)(Infant age 12 months)
Infant height (trajectories)(Infant age 12 months)
Infant head circumference (trajectories)(Infant age 12 months)
Infant gut microbiota(0 to 4 weeks)