Baby Formula and Health | NCT04559490

Studies
Baby Formula and Health

NCT04559490

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Oct 4, 2023Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Pancreas Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 16, 2020Actual

Primary Completion Date

Jun 9, 2022Actual

Completion Date

Sep 16, 2023Actual

First Submitted Date

Sep 16, 2020

First Submission Date that Met QC Criteria

Sep 16, 2020

First Posted Date

Sep 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2023

Last Update Posted Date

Oct 4, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Mothers and infants will be enrolled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center of the University of Rochester Medical Center		Rochester	New York	14642	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010182	Pancreatic Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided