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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02142647

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

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 :

Mar 1, 2014

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

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

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

Primary Outcome Measures

Change of linear growth [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

Change in Body composition [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

Change in gut microbiome [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

Criteria

Ages Eligible for Study:

1 Month to 5 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Nancy Krebs, MD, UC Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02142647

Other Study ID Numbers:

14-0139

First Posted:

May 20, 2014

Last Update Posted:

Jul 10, 2019

Last Verified:

Jul 1, 2019

Keywords provided by University of Colorado, Denver

Study Results

No Results Posted as of Jul 10, 2019