Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Altered breast milk lipidome
研究概览
简要总结
The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants.
详细描述
Epidemiological studies suggest that breastfeeding protects against risk of obesity, diabetes, asthma, and other childhood diseases. However, the specific compounds within breastmilk that are responsible for its protective effects are not fully understood. Moreover, prior work from this investigative team has shown that human milk composition varies substantially between individuals according to factors such as body mass index (BMI), diabetes status, diet, and physical activity. Gaining a better understanding of how modifiable risk factors may impact human milk composition would have the potential to identify strategies to enhance the health-promoting benefits of human milk.
In this project, the investigators will study the impact of maternal exercise on human milk composition. The central hypothesis is that maternal exercise induces changes in breast milk metabolites and lipids that result in activation of infant brown fat, increased infant energy expenditure, and reduced obesity risk.
The study will include assessments of habitual activity during pregnancy and the postpartum period, supervised bouts acute moderate exercise, as well as analysis of human milk composition, infant growth and body composition, and infant energy expenditure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-45 y of age at the time of enrollment
- •Pre-gravid or first trimester BMI 18.5 -40 kg/m2
- •Uncomplicated singleton pregnancy
- •Intention to exclusively breastfeed for >3 months and, if parity >1, that they successfully breastfed a previous pregnancy
- •Term pregnancy (gestational age 37 to <42 weeks)
- •Infant with birth weight >10th percentile of weight for gestational age
排除标准
- •Any obstetric contra-indication to exercise at 1 month
- •Diagnosis of uncontrolled (HbA1c >7%) type 1 or type 2 diabetes, or gestational diabetes managed with insulin
- •Intrauterine growth restriction
- •Pre-eclampsia or other pregnancy complications
- •Alcohol, cannabis or tobacco use
- •Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth
- •Major fetal anomalies
- •Musculoskeletal issues that would make exercise difficult
研究组 & 干预措施
Enhanced physical activity
Participants in this group will be encouraged to engage in daily physical activity
干预措施: Active group (Behavioral)
Control group
Usual care
结局指标
主要结局
Altered breast milk lipidome
时间窗: 8 weeks
Milk composition measured through lipidomics
Altered breast milk metabolome
时间窗: 8 weeks
Human milk composition measured via metabolomics
次要结局
- Infant body composition(3 months, 6 months, and 12 months)
- Infant body mass index (BMI)(3 months, 6 months, and 12 months)
- Infant resting metabolic rate(3 months of age)