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

Infant Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142647
• Other study ID #: 14-0139
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 2018

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Body Fat
• Infant Growth
• Infant Gut Microbiome

Intervention

Behavioral:
• a high-protein complementary diet with meat
infants will consume a high-protein complementary diet with protein mainly from meat
• a high-protein complementary diet with dairy
infants will consume a high-protein complementary diet with protein mainly from dairy

Locations

Country	Name	City	State
United States	UC Denver	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado Clinical & Translational Sciences Institute, National Cattlemen's Beef Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gut microbiome	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
Primary	Change of linear growth	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	Change in Body composition	body composition: fat mass, fat-free mass will be assessed at the beginning and end of the study	5 and 12 months of age