Modulating Early-life Nutrition for Childhood Obesity Prevention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in weight-for-length z score
研究概览
简要总结
In this study, betaine intake will be increased in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed with the supplementation group (infant formula supplemented with betaine) and control group (unsupplemented infant formula). The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth.
详细描述
Childhood obesity is one of the main public health concerns worldwide. Previous results have linked a nutrient called betaine (trimethylglycine) to the risk of childhood obesity. Betaine is a modified amino acid with osmotic properties that participates in the methionine cycle as a methyl group donor. Specifically, previous data demonstrate a link between breast milk betaine content, postnatal growth, and long-term metabolic health, suggesting that betaine supplementation may be an effective strategy for regulating growth trajectories and preventing childhood obesity. This study will assess the effects of increasing betaine intake in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed where participants will be randomly assigned to the control group or the supplementation group. The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth. Additionally, potential changes in the intestinal microbiome induced by the increase in betaine intake will be analyzed.
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
- 0 Weeks 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maternal age between 17 and 42 years
- •Maternal pre-pregnancy BMI equal or higher than 25
- •Gestational age at birth > 37 weeks
- •No exclusive breastfeeding at time of recruitment
排除标准
- •Presence of disease or malformations in the infant
- •Infant birth weight < -1 SD (standard deviations)
- •Multiple pregnancy
- •Elective c-section
结局指标
主要结局
Change in weight-for-length z score
时间窗: From start to the end of treatment at 12 weeks and at 12 months of follow-up
Weight and length will be measured at different time-points and combined to calculate weight-for-length z scores.
Changes in fecal microbiota composition
时间窗: At 4 weeks and 12 weeks end of treatment, and at 12 months of follow-up
Differences in features associated with a healthy mucosal layer and metabolic state (e.g. Bifidobacteria and Akkermansia relative amount). Stool samples will be processed to isolate the bacterial DNA. Microbiome composition will be determined by DNA sequencing.
次要结局
- Urine one-carbon metabolite concentration(At 4 weeks and 12 weeks after start of treatment)
- Infant body composition(At 12 months of follow-up)