How Infant Diets Would Affect Growth in Early Childhood

Body Composition Clinical Trial

— FYI-FU  

Official title:

Effect of Complementary Feeding With Different Macronutrient Quantities on Growth and Body Composition: a Follow-up Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440503
• Other study ID #: 14-0489
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• First received: June 25, 2014
• Last updated: October 24, 2017
• Start date: June 2014
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that included breastfed infants consuming different infant solid foods. The investigators results showed that different solid foods, especially the protein content of the food, is important on infant's gut bacteria profile and growth. Although the first year of life is critical in obesity development later in life, data are very limited on the effect of protein from solid foods, an important component of infant diet, especially in breast-fed infants. In this study, the investigators will re-contact these participants, who are now in their early childhood (~5 years old), to evaluate the long-term effect of various macronutrient quantities in solid foods, by assessing the participants' growth, body composition, and gut bacteria profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• Those participants who completed the initial trial when they were infants.

Exclusion Criteria:

Related Conditions & MeSH terms

• Body Composition
• Growth
• Gut Health

Locations

Country	Name	City	State
United States	UC Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age adjusted height	observational, one time assessment. The hospital visit is scheduled according to the participant's availability.	Day 1: one time assessment during the participant's visit to Colorado Children's hospital
Primary	Age adjusted weight	observational, one time assessment. The hospital visit is scheduled according to the participant's availability.	Day 1: one time assessment during the participant's visit to Colorado Children's hospital
Secondary	Percent body fat	Body composition using DEXA scan will be assessed during the hospital visit	Day 1: one time assessment during the participant's visit to Colorado Children's hospital