Clinical trial NCT04434027: The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
Official title: Mother's Milk Study: Determining the Impact of Human Milk Oligosaccharides (HMOs) on Healthy Infant Growth and Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: microbiome
nutrition
obesity
growth
breastfeeding
mother
infant
cognitive development
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: University of California, San Diego
First posted: 2020-06-16
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal, overweight or obese (\>25 BMI kg/m2) non-diabetic Hispanic mothers (18-59yrs) and their infants (\<1-36 months) from Los Angeles, CA.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Infant weight z-scores at baseline
timeFrame: Baseline
measure: Infant weight z-scores at 6 months
timeFrame: 6 months
measure: Infant weight z-scores at 12 months
timeFrame: 12 months
measure: Infant weight z-scores at 18 months
timeFrame: 18 months
measure: Infant weight z-scores at 24 months
timeFrame: 24 months
measure: Infant weight z-scores at 36 months
timeFrame: 36 months
measure: Infant skinfold thickness at baseline
timeFrame: Baseline
measure: Infant skinfold thickness at 6 months
timeFrame: 6 months
measure: Infant skinfold thickness at 12 months
timeFrame: 12 months
measure: Infant skinfold thickness at 18 months
timeFrame: 18 months
measure: Infant skinfold thickness at 24 months
timeFrame: 24 months
measure: Infant skinfold thickness at 36 months
timeFrame: 36 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant body fat measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at 18 months
timeFrame: 18 months
measure: Infant body fat measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 18 months
timeFrame: 18 months
measure: Infant lean mass measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant total body water measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at 18 months
timeFrame: 18 months
measure: Infant total body water measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at baseline
timeFrame: Baseline
measure: Infant free body water measured using an EchoMRI body composition analyzer at 6 months
timeFrame: 6 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at 12 months
timeFrame: 12 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at 18 months
timeFrame: 18 months
measure: Infant free body water measured using an EchoMRI body composition analyzer at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Maternal pregravid BMI
timeFrame: Baseline
measure: Maternal height at baseline
timeFrame: Baseline
measure: Maternal height at 6 months
timeFrame: 6 months
measure: Maternal height at 12 months
timeFrame: 12 months
measure: Maternal height at 18 months
timeFrame: 18 months
measure: Maternal height at 24 months
timeFrame: 24 months
measure: Maternal weight at baseline
timeFrame: Baseline
measure: Maternal weight at 6 months
timeFrame: 6 months
measure: Maternal weight at 12 months
timeFrame: 12 months
measure: Maternal weight at 18 months
timeFrame: 18 months
measure: Maternal weight at 24 months
timeFrame: 24 months
measure: Maternal BMI at baseline
timeFrame: Baseline
measure: Maternal BMI at 6 months
timeFrame: 6 months
measure: Maternal BMI at 12 months
timeFrame: 12 months
measure: Maternal BMI at 18 months
timeFrame: 18 months
measure: Maternal BMI at 24 months
timeFrame: 24 months
measure: Infant length at baseline
timeFrame: Baseline
measure: Infant length at 6 months
timeFrame: 6 months
measure: Infant length at 12 months
timeFrame: 12 months
measure: Infant length at 18 months
timeFrame: 18 months
measure: Infant length at 24 months
timeFrame: 24 months
measure: Infant length at 36 months
timeFrame: 36 months
measure: Infant weight at baseline
timeFrame: Baseline
measure: Infant weight at 6 months
timeFrame: 6 months
measure: Infant weight at 12 months
timeFrame: 12 months
measure: Infant weight at 18 months
timeFrame: 18 months
measure: Infant weight at 24 months
timeFrame: 24 months
measure: Infant weight at 36 months
timeFrame: 36 months
measure: Maternal systolic and diastolic blood pressure at baseline
timeFrame: Baseline
measure: Maternal systolic and diastolic blood pressure at 6 months
timeFrame: 6 months
measure: Maternal systolic and diastolic blood pressure at 12 months
timeFrame: 12 months
measure: Maternal systolic and diastolic blood pressure at 18 months
timeFrame: 18 months
measure: Maternal systolic and diastolic blood pressure at 24 months
timeFrame: 24 months
measure: Maternal resting heart rate at baseline
timeFrame: Baseline
measure: Maternal resting heart rate at 6 months
timeFrame: 6 months
measure: Maternal resting heart rate at 12 months
timeFrame: 12 months
measure: Maternal resting heart rate at 18 months
timeFrame: 18 months
measure: Maternal resting heart rate at 24 months
timeFrame: 24 months
measure: Maternal diet at baseline
timeFrame: Baseline
measure: Maternal diet at 6 months
timeFrame: 6 months
measure: Maternal diet at 12 months
timeFrame: 12 months
measure: Maternal diet at 18 months
timeFrame: 18 months
measure: Maternal diet at 24 months
timeFrame: 24 months
measure: Infant diet at baseline
timeFrame: Baseline
measure: Infant diet at 6 months
timeFrame: 6 months
measure: Infant diet at 12 months
timeFrame: 12 months
measure: Infant diet at 18 months
timeFrame: 18 months
measure: Infant diet at 24 months
timeFrame: 24 months
measure: Infant diet at 36 months
timeFrame: 36 months
measure: Maternal beverage recall during last trimester of pregnancy
timeFrame: Baseline
measure: Maternal beverage recall at baseline
timeFrame: Baseline
measure: Maternal beverage recall at 6 months
timeFrame: 6 months
measure: Maternal beverage recall at 12 months
timeFrame: 12 months
measure: Maternal beverage recall at 18 months
timeFrame: 18 months
measure: Maternal beverage recall at 24 months
timeFrame: 24 months
measure: Infant beverage recall at baseline
timeFrame: Baseline
measure: Infant beverage recall at 6 months
timeFrame: 6 months
measure: Infant beverage recall at 12 months
timeFrame: 12 months
measure: Infant beverage recall at 18 months
timeFrame: 18 months
measure: Infant beverage recall at 24 months
timeFrame: 24 months
measure: Infant beverage recall at 36 months
timeFrame: 36 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at baseline
timeFrame: Baseline
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 6 months
timeFrame: 6 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 12 months
timeFrame: 12 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 18 months
timeFrame: 18 months
measure: Infant feeding score assessed by Infant Feeding Questionnaire at 24 months
timeFrame: 24 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at baseline
timeFrame: Baseline
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 6 months
timeFrame: 6 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 12 months
timeFrame: 12 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 18 months
timeFrame: 18 months
measure: Infant feeding style score assessed by Infant Feeding Style Questionnaire at 24 months
timeFrame: 24 months
measure: Infant behavior score assessed by Infant Behavior Questionnaire at baseline
timeFrame: Baseline
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 6 months
timeFrame: 6 months
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 12 months
timeFrame: 12 months
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 18 months
timeFrame: 18 months
measure: Infant behavior score assessed by Infant Behavior Questionnaire at 24 months
timeFrame: 24 months
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at baseline
timeFrame: Baseline
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 6 months
timeFrame: 6 months
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 12 months
timeFrame: 12 months
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 18 months
timeFrame: 18 months
measure: Infant eating behavior score assessed by Baby Eating Behavior Questionnaire at 24 months
timeFrame: 24 months
measure: Infant diet score assessed by Infant Diet Questionnaire at baseline
timeFrame: Baseline
measure: Infant diet score assessed by Infant Diet Questionnaire at 6 months
timeFrame: 6 months
measure: Infant diet score assessed by Infant Diet Questionnaire at 12 months
timeFrame: 12 months
measure: Infant diet score assessed by Infant Diet Questionnaire at 18 months
timeFrame: 18 months
measure: Infant diet score assessed by Infant Diet Questionnaire at 24 months
timeFrame: 24 months
measure: Infant development assessed by the Bayley Scales of Infant and Toddler Development at 24 months
timeFrame: 24 months
measure: Infant Magnetic Resonance Imaging (MRI) brain scan at baseline
timeFrame: Baseline
measure: Infant Magnetic Resonance Imaging (MRI) brain scan at 6 months
timeFrame: 6 months
measure: Infant development assessed by the Adaptive Behavior Assessment System at 36 months
timeFrame: 36 months
measure: Breast milk composition at baseline
timeFrame: Baseline
measure: Breast milk composition at 6 months
timeFrame: 6 months
measure: Breast milk composition at 12 months
timeFrame: 12 months
measure: Breast milk composition at 18 months
timeFrame: 18 months
measure: Breast milk composition at 24 months
timeFrame: 24 months
measure: Infant gut microbiome at baseline
timeFrame: Baseline
measure: Infant gut microbiome at 6 months
timeFrame: 6 months
measure: Infant gut microbiome at 12 months
timeFrame: 12 months
measure: Infant gut microbiome at 18 months
timeFrame: 18 months
measure: Infant gut microbiome at 24 months
timeFrame: 24 months
measure: Infant gut microbiome at 36 months
timeFrame: 36 months
measure: Maternal gut microbiome at baseline
timeFrame: Baseline
measure: Maternal gut microbiome at 6 months
timeFrame: 6 months
measure: Maternal gut microbiome at 12 months
timeFrame: 12 months
measure: Maternal gut microbiome at 18 months
timeFrame: 18 months
measure: Maternal gut microbiome at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: University of Southern California; Children's Hospital Los Angeles
name: Michael I Goran, PhD
role: PRINCIPAL_INVESTIGATOR
References: