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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Pancreas Disease
• Pancreatic Diseases

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