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Effect of Protein From Complementary Foods on Infant Growth, Body Composition and Gut Health

NCT02142647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-07-10

No results posted yet for this study

Summary

Current research shows that dairy protein accelerates infant weight gain, which is a risk factor for later on obesity and metabolic syndrome. However, dietary protein from other sources haven't been studied yet. This longitudinal study will compare two complementary feeding regimens with dietary protein mainly from 1) meat; 2) dairy on infant growth, body composition and gut microbiome from 5 to 12 months of age in formula fed infants. Healthy infants at approximately 5 months of age will be randomized to either a meat protein, or a dairy protein group with complementary protein mainly from meat or dairy. Infants will consume one of these diets for 7 months (6-12 months of age) and infant growth, body composition, growth biomarkers and gut microbiome will be measured to compare between groups and over time.

Conditions

  • Infant Growth
  • Infant Body Fat
  • Infant Gut Microbiome

Interventions

BEHAVIORAL

a high-protein complementary diet with meat

infants will consume a high-protein complementary diet with protein mainly from meat

BEHAVIORAL

a high-protein complementary diet with dairy

infants will consume a high-protein complementary diet with protein mainly from dairy

Sponsors & Collaborators

  • Colorado Clinical & Translational Sciences Institute

    collaborator OTHER

  • National Cattlemen's Beef Association

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Nancy Krebs, MD · UC Denver

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02142647 on ClinicalTrials.gov