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

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ClinicalTrials.gov Identifier: NCT02440503
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
Growth Body Composition Gut Health

Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effect of Complementary Feeding With Different Macronutrient Quantities on Growth and Body Composition: a Follow-up Trial
Study Start Date : June 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
stool samples will be collected for microbiome analysis


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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children 4-6 years of age
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440503


Locations
United States, Colorado
UC Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Minghua Tang, PhD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02440503     History of Changes
Other Study ID Numbers: 14-0489
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017