Pancreas Disease Clinical Trial
Official title:
Formula - Understanding Nutrition (FUN)
Verified date | October 2023 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Research Center of the University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
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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