Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02142647
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
Colorado Clinical & Translational Sciences Institute
National Cattlemen's Beef Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Infant Growth Infant Body Fat Infant Gut Microbiome Behavioral: a high-protein complementary diet with meat Behavioral: a high-protein complementary diet with dairy Not Applicable

Detailed Description:
Two observational follow-up visits will be conducted at 18 and 24 months of age.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Dietary Protein From Meat vs. Dairy on Infant Growth, Body Composition and Gut Health
Study Start Date : March 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Proteins

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142647


Locations
Layout table for location information
United States, Colorado
UC Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
National Cattlemen's Beef Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Nancy Krebs, MD UC Denver
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02142647    
Other Study ID Numbers: 14-0139
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by University of Colorado, Denver:
infant growth
dietary protein
body composition
gut microbiome