Maternal Betaine Supplementation During Breastfeeding
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change from birth weight-for-length z score at 1 month
研究概览
简要总结
Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Our previous results in humans demonstrate that lower breast milk betaine levels were associated with faster infant postnatal growth, a strong and potentially modifiable risk factor of future obesity. Betaine is a trimethylated derivative of glycine, which is present in multiple foods and occurs naturally in breast milk. In this study, we will perform a double-blind randomized placebo-controlled pilot clinical study, in which maternal diet will be supplemented with betaine for 3 months during breastfeeding; infant's growth and adiposity will be monitored until 12 months of age, and breast milk composition and gut microbiota analyzed. An additional follow-up visit will be conducted at 48 months of age to repeat microbiome analysis, determine adiposity, and perform cognitive development assessment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal Pre-pregnancy BMI between 25 and
- •Willing to exclusively breastfeed for ≥ 3 months
- •Infant gestational age at birth > 37 weeks
- •Infant birth weight > -1 standard deviations
- •Absence of infant disease or malformations at birth
排除标准
- •Multiple pregnancy
- •Lactose intolerance
- •CBS deficiency (inherited disease)
结局指标
主要结局
Change from birth weight-for-length z score at 1 month
时间窗: Birth and 1 month
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Change from birth weight-for-length z score at 3 months
时间窗: Birth and 3 months
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
次要结局
- Change from birth weight-for-length z score at 6 months(Birth and 6 months)
- Change from birth weight-for-length z score at 12 months(Birth and 12 months)
- Maternal gut microbiome composition(1 and 3 months)
- Maternal circulating concentration of betaine and related metabolites(1 and 3 months)
- Breast milk concentration of betaine and related metabolites(1 and 3 months)
- Infant urine concentration of betaine and related metabolites(1, 3, and 6, and 12 months)
- Change from birth weight-for-length z score at 48 months(Birth and 48 months)
- Infant Body composition(3, 12 and 48 months)
- Infant gut microbiome composition(1, 3, 6, 12 and 48 months)