How Infant Diets Would Affect Growth in Early Childhood
FYI-FU
Effect of Complementary Feeding With Different Macronutrient Quantities on Growth and Body Composition: a Follow-up Trial
2 other identifiers
observational
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 25, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 26, 2017
October 1, 2017
3.2 years
June 25, 2014
October 24, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Percent body fat
Day 1: one time assessment during the participant's visit to Colorado Children's hospital
Eligibility Criteria
Children 4-6 years of age
You may qualify if:
- Those participants who completed the initial trial when they were infants.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Denver
Aurora, Colorado, 80045, United States
Biospecimen
stool samples will be collected for microbiome analysis
Study Officials
- PRINCIPAL INVESTIGATOR
Minghua Tang, PhD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2014
First Posted
May 12, 2015
Study Start
June 1, 2014
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
October 26, 2017
Record last verified: 2017-10