Baby Formula and Health

Completed

• Conditions: Pancreas Disease

• Registration Number: NCT04559490
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Primary Completion: 2022-06-09
• Study Completion: 2023-09-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean change in blood glucose	baseline to 1 hour	change in blood glucose from fasting to 1 hour post glucose challenge

Secondary Outcome Measures

Name	Time	Method
mean endogenous insulin secretion	baseline to 1 hour	change in mean insulin collected at baseline and 1 hour post glucose challenge

Trial Locations

Locations (1)

Clinical Research Center of the University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States