Baby Formula and Health

NCT ID: NCT04559490

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-16

Study Completion Date

2023-09-16

Brief Summary

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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

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Conditions

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Pancreas Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard formula

Participants receiving intact protein lactose-based formula, exclusively for at least 3 months.

No interventions assigned to this group

Sensitive

Participants receiving intact protein glucose/sucrose- based formula, exclusively for at least 3 months.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Bridget Young

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Research Center of the University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004724

Identifier Type: -

Identifier Source: org_study_id

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