NCT05488964进行中（未招募）不适用
Exercised Breastmilk: A Randomised Controlled Trial on the Effect of Exercise Training During Lactation on Breastmilk Composition
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Breastmilk human milk oligosaccharide (HMO) 3'sialyllactose (3'SL)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
Experimental
Regular endurance training for 8 weeks
干预措施: Exercise (Behavioral)
Control
No Intervention
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)
研究者
研究点 (2)
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