Mother's Milk Study: Determining the Impact of Human Milk Oligosaccharides (HMOs) on Healthy Infant Growth and Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Infant weight z-scores at baseline
研究概览
简要总结
This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains certain natural sugars that can promote the growth of 'good' bacteria in the intestines and reduce the growth of harmful bacteria. The purpose of this study is to look at the effects of these natural sugars in breast milk on the infant's bacteria and the impact of this on development of obesity and cognitive outcomes by 2 years of age with plans for longer term follow up contingent upon funding.
详细描述
This project will examine specific factors in breast milk that may impact infant's gut microbiome development, and thereby impact their adiposity and weight gain in early life. An important early-life experience that could meaningfully impact the development of the gut microbiome, as well as future obesity risk, is breastfeeding. Breast milk has been shown to contain certain macronutrients (human milk oligosaccharides; HMOs) that not only vary greatly among women, but recent studies suggest that these factors are significant predictors of infant weight gain and adiposity. Examining early onset obesity during infancy is important because accelerated weight gain and adiposity in the first few years of life are major predictors for later obesity, and because neuronal, metabolic, and gut microbiome systems are especially vulnerable by programming from nutritional and maternal factors during this stage of life.
This study will be conducted in Los Angeles. The investigators will recruit two-hundred-and-forty mother-infant pairs. Mothers and infants will be monitored during the first 36 months of life, with sampling of breast milk (while the mother is still breast feeding) and infant and maternal stool at 1, 6, 12, 18, and 24 months of age (or as close as possible to each month). Only an infant stool sample will be collected at 36 months of age. The main outcomes of this study will be infant body weight-for-length growth during this period, as well as body composition (fat and lean mass), which will be measured by skin-fold thickness using a caliber, height, weight, and waist circumference measurements at 1, 6, 12, 18, 24, and 36 months of infant age (or as close as possible to each month). The investigators will also assess maternal and infant diet using 24-hour recalls, and maternal feeding style and infant eating behaviors using questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers who self-identify as Hispanic
- •Mothers who have or have had singleton births
- •Mothers will be recruited prior to their infant's birth or up to 1-month postpartum
- •Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
排除标准
- •Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
- •Physical, mental, or cognitive issues that prevent participation
- •Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
- •Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
- •Clinical diagnosis of gestational diabetes
- •Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
- •Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth
结局指标
主要结局
Infant weight z-scores at baseline
时间窗: Baseline
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.
Infant weight z-scores at 24 months
时间窗: 24 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.
Infant body fat measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant body fat measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 18 months
时间窗: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant total body water measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant weight z-scores at 6 months
时间窗: 6 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.
Infant weight z-scores at 12 months
时间窗: 12 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.
Infant skinfold thickness at 12 months
时间窗: 12 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant total body water measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant skinfold thickness at baseline
时间窗: Baseline
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant body fat measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant weight z-scores at 18 months
时间窗: 18 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.
Infant skinfold thickness at 6 months
时间窗: 6 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant skinfold thickness at 18 months
时间窗: 18 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant body fat measured using an EchoMRI body composition analyzer at 18 months
时间窗: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at baseline
时间窗: Baseline
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant weight z-scores at 36 months
时间窗: 36 months
Weight and length will be used to calculate weight-for-length (WLZ) and weight-for-age (WAZ) z-scores using the WHO Child Growth Standards, as recommended by the CDC for children \<24 mos.
Infant skinfold thickness at 24 months
时间窗: 24 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant skinfold thickness at 36 months
时间窗: 36 months
Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.
Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 18 months
时间窗: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 6 months
时间窗: 6 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 12 months
时间窗: 12 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
Infant total body water measured using an EchoMRI body composition analyzer at 24 months
时间窗: 24 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.
Infant free body water measured using an EchoMRI body composition analyzer at 18 months
时间窗: 18 months
An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.
次要结局
- Maternal pregravid BMI(Baseline)
- Maternal height at 18 months(18 months)
- Maternal height at 24 months(24 months)
- Maternal weight at baseline(Baseline)
- Maternal weight at 6 months(6 months)
- Maternal weight at 12 months(12 months)
- Maternal weight at 18 months(18 months)
- Maternal height at baseline(Baseline)
- Maternal height at 6 months(6 months)
- Maternal height at 12 months(12 months)
- Maternal weight at 24 months(24 months)
- Maternal BMI at baseline(Baseline)
- Maternal BMI at 6 months(6 months)
- Maternal BMI at 12 months(12 months)
- Maternal BMI at 24 months(24 months)
- Infant length at 6 months(6 months)
- Infant length at 12 months(12 months)
- Infant length at 18 months(18 months)
- Infant length at 24 months(24 months)
- Infant weight at 18 months(18 months)
- Infant weight at 36 months(36 months)
- Maternal systolic and diastolic blood pressure at 6 months(6 months)
- Maternal systolic and diastolic blood pressure at 18 months(18 months)
- Maternal resting heart rate at 24 months(24 months)
- Infant diet at 18 months(18 months)
- Maternal beverage recall during last trimester of pregnancy(Baseline)
- Maternal BMI at 18 months(18 months)
- Infant length at baseline(Baseline)
- Infant length at 36 months(36 months)
- Infant weight at 12 months(12 months)
- Maternal systolic and diastolic blood pressure at baseline(Baseline)
- Maternal resting heart rate at baseline(Baseline)
- Maternal resting heart rate at 6 months(6 months)
- Maternal resting heart rate at 18 months(18 months)
- Infant weight at baseline(Baseline)
- Infant diet at baseline(Baseline)
- Infant diet at 12 months(12 months)
- Maternal beverage recall at 24 months(24 months)
- Infant beverage recall at baseline(Baseline)
- Infant beverage recall at 6 months(6 months)
- Infant beverage recall at 12 months(12 months)
- Infant beverage recall at 18 months(18 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at 18 months(18 months)
- Infant weight at 6 months(6 months)
- Maternal systolic and diastolic blood pressure at 12 months(12 months)
- Maternal diet at 12 months(12 months)
- Maternal diet at 24 months(24 months)
- Infant diet at 6 months(6 months)
- Infant diet at 24 months(24 months)
- Infant weight at 24 months(24 months)
- Maternal systolic and diastolic blood pressure at 24 months(24 months)
- Maternal resting heart rate at 12 months(12 months)
- Maternal beverage recall at 6 months(6 months)
- Maternal diet at baseline(Baseline)
- Maternal diet at 6 months(6 months)
- Maternal diet at 18 months(18 months)
- Infant diet at 36 months(36 months)
- Maternal beverage recall at baseline(Baseline)
- Maternal beverage recall at 12 months(12 months)
- Maternal beverage recall at 18 months(18 months)
- Infant beverage recall at 24 months(24 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at baseline(Baseline)
- Infant beverage recall at 36 months(36 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at 6 months(6 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 18 months(18 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months(24 months)
- Infant behavior score assessed by Infant Behavior Questionnaire at 6 months(6 months)
- Infant behavior score assessed by Infant Behavior Questionnaire at 18 months(18 months)
- Infant behavior score assessed by Infant Behavior Questionnaire at 24 months(24 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at 12 months(12 months)
- Infant feeding score assessed by Infant Feeding Questionnaire at 24 months(24 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline(Baseline)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months(6 months)
- Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months(12 months)
- Infant behavior score assessed by Infant Behavior Questionnaire at baseline(Baseline)
- Infant behavior score assessed by Infant Behavior Questionnaire at 12 months(12 months)
- Infant diet score assessed by Infant Diet Questionnaire at baseline(Baseline)
- Breast milk composition at 18 months(18 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline(Baseline)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 18 months(18 months)
- Infant Magnetic Resonance Imaging (MRI) brain scan at baseline(Baseline)
- Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months(6 months)
- Breast milk composition at 12 months(12 months)
- Infant gut microbiome at baseline(Baseline)
- Infant gut microbiome at 6 months(6 months)
- Infant gut microbiome at 12 months(12 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months(6 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months(12 months)
- Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 24 months(24 months)
- Infant diet score assessed by Infant Diet Questionnaire at 18 months(18 months)
- Infant diet score assessed by Infant Diet Questionnaire at 24 months(24 months)
- Infant development assessed by the Bayley Scales of Infant and Toddler Development at 24 months(24 months)
- Infant diet score assessed by Infant Diet Questionnaire at 6 months(6 months)
- Infant diet score assessed by Infant Diet Questionnaire at 12 months(12 months)
- Infant gut microbiome at 24 months(24 months)
- Infant gut microbiome at 36 months(36 months)
- Infant development assessed by the Adaptive Behavior Assessment System at 36 months(36 months)
- Breast milk composition at baseline(Baseline)
- Breast milk composition at 6 months(6 months)
- Breast milk composition at 24 months(24 months)
- Maternal gut microbiome at 12 months(12 months)
- Maternal gut microbiome at 18 months(18 months)
- Infant gut microbiome at 18 months(18 months)
- Maternal gut microbiome at 24 months(24 months)
- Maternal gut microbiome at baseline(Baseline)
- Maternal gut microbiome at 6 months(6 months)
研究者
Michael I. Goran
Principal Investigator
University of Southern California