How Infant Diets Would Affect Growth in Early Childhood (FYI-FU)

October 24, 2017 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

75

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children 4-6 years of age

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age adjusted height
Time Frame: Day 1: one time assessment during the participant's visit to Colorado Children's hospital
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
Age adjusted weight
Time Frame: Day 1: one time assessment during the participant's visit to Colorado Children's hospital
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent body fat
Time Frame: Day 1: one time assessment during the participant's visit to Colorado Children's hospital
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

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

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

June 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14-0489
  • UL1TR001082 (U.S. NIH Grant/Contract)

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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