Skip to main content
OpenTrials
Completed

NCT Number: NCT02142647

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant Growth Infant Body Fat Infant Gut Microbiome

Age range

1 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Denver

Aurora, Colorado, 80045, United States

About this study

Two observational follow-up visits will be conducted at 18 and 24 months of age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1-5 months of age
  • Formula fed
  • On breast milk less than 1 month
  • Healthy
  • Term Birth (36-42 weeks)
  • Appropriate for gestational age

Exclusion criteria

  • Congenital anomalies that impact feeding, growth, or development
  • Low birth weight
  • Not able to consume milk-based formula
  • Known chronic diseases or allergies affecting protein consumption/digestion

Treatment and study plan

a high-protein complementary diet with meat

Behavioral

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

a high-protein complementary diet with dairy

Behavioral

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

Primary outcomes

  1. Change of linear growth

    Time frame: 6 months

    growth, including linear growth (length), body weight, and all the Z scores will be recorded at the beginning and end of the study.

Secondary outcomes

  1. Change in Body composition

    Time frame: 5 and 12 months of age

    body composition: fat mass, fat-free mass will be assessed at the beginning and end of the study

Other outcomes

  1. Change in gut microbiome

    Time frame: 5, 9.5 and 12 months of age

    Gut microbiota profile will be measured at the beginning, mid point, and end of the intervention by collecting stool samples

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Colorado Clinical & Translational Sciences Institute
  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 20, 2014
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.