NCT04434027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

6.1 years

First QC Date

June 12, 2020

Last Update Submit

March 27, 2025

Conditions

Obesity

Keywords

microbiomenutritionobesitygrowthbreastfeedingmotherinfantcognitive development

Outcome Measures

Primary Outcomes (32)

  • Infant weight z-scores at 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.

    Baseline

  • Infant weight z-scores at 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.

    6 months

  • Infant weight z-scores at 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.

    12 months

  • Infant weight z-scores at 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.

    18 months

  • Infant weight z-scores at 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.

    24 months

  • Infant weight z-scores at 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.

    36 months

  • Infant skinfold thickness at baseline

    Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.

    Baseline

  • Infant skinfold thickness at 6 months

    Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.

    6 months

  • Infant skinfold thickness at 12 months

    Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.

    12 months

  • Infant skinfold thickness at 18 months

    Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.

    18 months

  • Infant skinfold thickness at 24 months

    Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.

    24 months

  • Infant skinfold thickness at 36 months

    Infant skinfold thickness will be measured in duplicate using a commercial caliper at the following sites: tricep, subscapular, suprailiac, and midthigh.

    36 months

  • Infant body fat measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    Baseline

  • Infant body fat measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    6 months

  • Infant body fat measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    12 months

  • Infant body fat measured using an EchoMRI body composition analyzer at 18 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    18 months

  • Infant body fat measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant body fat in grams.

    24 months

  • Infant lean mass measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    Baseline

  • Infant lean mass measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    6 months

  • Infant lean mass measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    12 months

  • Infant lean mass measured using an EchoMRI body composition analyzer at 18 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    18 months

  • Infant lean mass measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant lean mass in grams.

    24 months

  • Infant total body water measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    Baseline

  • Infant total body water measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    6 months

  • Infant total body water measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    12 months

  • Infant total body water measured using an EchoMRI body composition analyzer at 18 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    18 months

  • Infant total body water measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant total body water in grams.

    24 months

  • Infant free body water measured using an EchoMRI body composition analyzer at baseline

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    Baseline

  • Infant free body water measured using an EchoMRI body composition analyzer at 6 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    6 months

  • Infant free body water measured using an EchoMRI body composition analyzer at 12 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    12 months

  • Infant free body water measured using an EchoMRI body composition analyzer at 18 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    18 months

  • Infant free body water measured using an EchoMRI body composition analyzer at 24 months

    An EchoMRI infant body composition analyzer (EchoMRI LLC., Houston TX) will be used to measure infant free body water in grams.

    24 months

Secondary Outcomes (106)

  • Maternal pregravid BMI

    Baseline

  • Maternal height at baseline

    Baseline

  • Maternal height at 6 months

    6 months

  • Maternal height at 12 months

    12 months

  • Maternal height at 18 months

    18 months

  • +101 more secondary outcomes

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Breast milk; Stool (mother and infant)

MeSH Terms

Conditions

ObesityBreast Feeding

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Michael I Goran, PhD

    University of Southern California; Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 16, 2020

Study Start

July 1, 2016

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

US(1)