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NCT04559490 Clinical Trial

Baby Formula and Health

Pancreas Disease Clinical Trial

Official title:
Formula - Understanding Nutrition (FUN)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04559490
Other study ID # STUDY00004724
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 16, 2020
Est. completion date September 16, 2023

Study information
Verified date October 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to learn about how different types of carbohydrates used in infant formula may affect a baby's intestines and pancreas.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date September 16, 2023
Est. primary completion date June 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Months and older
Eligibility Inclusion Criteria: - Mothers = 19 years of age - Singleton birth - Healthy Infants - Infant between 3-6 months at the time of visit and exclusively fed one of the formulas for a minimum of 3 months Exclusion Criteria: - Delivery before 35 weeks - Infant birth weight <2500g - Infants exhibiting growth faltering (loss of more than 25 percentile points) between 1 month to the time of study visit for either weight or length. - Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns. - Infant consumption of more than two servings of complementary foods per day before the study visit.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Clinical Research Center of the University of Rochester Medical Center Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean change in blood glucose change in blood glucose from fasting to 1 hour post glucose challenge baseline to 1 hour
Secondary mean endogenous insulin secretion change in mean insulin collected at baseline and 1 hour post glucose challenge baseline to 1 hour
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