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

July 8, 2019 updated by: University of Colorado, Denver

Effects of Dietary Protein From Meat vs. Dairy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UC Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 5 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: meat group
Infants in this group will receive complementary foods with high protein content mainly from meat
Behavioral: a high-protein complementary diet with meat
infants will consume a high-protein complementary diet with protein mainly from meat
Active Comparator: dairy group
infants in this group will receive complementary foods mainly from dairy
Behavioral: a high-protein complementary diet with dairy
infants will consume a high-protein complementary diet with protein mainly from dairy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 and 12 months of age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5, 9.5 and 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Colorado Clinical & Translational Sciences Institute
National Cattlemen's Beef Association

Investigators

  • Principal Investigator: Nancy Krebs, MD, UC Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-0139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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