Baby Formula and Health

Formula - Understanding Nutrition (FUN)

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.

Study Overview

• Status: Completed
• Conditions: Pancreas Disease

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Clinical Research Center of the University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Mothers and infants will be enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Standard formula; Participants receiving intact protein lactose-based formula, exclusively for at least 3 months.
Sensitive; Participants receiving intact protein glucose/sucrose- based formula, exclusively for at least 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean change in blood glucose	change in blood glucose from fasting to 1 hour post glucose challenge	baseline to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean endogenous insulin secretion	change in mean insulin collected at baseline and 1 hour post glucose challenge	baseline to 1 hour

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): September 16, 2023

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: STUDY00004724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No