NCT04559490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

September 16, 2020

Last Update Submit

October 3, 2023

Conditions

Pancreas Disease

Outcome Measures

Primary Outcomes (1)

  • mean change in blood glucose

    change in blood glucose from fasting to 1 hour post glucose challenge

    baseline to 1 hour

Secondary Outcomes (1)

  • mean endogenous insulin secretion

    baseline to 1 hour

Study Arms (2)

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.

Eligibility Criteria

Age5 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mothers and infants will be enrolled.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center of the University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 23, 2020

Study Start

September 16, 2020

Primary Completion

June 9, 2022

Study Completion

September 16, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations

US(1)