Baby Formula and Health

Formula - Understanding Nutrition (FUN)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04559490

Enrollment

Registered

2020-09-23

Start date

2020-09-16

Completion date

2023-09-16

Last updated

2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Months to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results