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OpenTrials
Completed

NCT Number: NCT04559490

Baby Formula and Health

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.

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Key information

Conditions

Pancreas Disease Digestive System Diseases Pancreatic Diseases

Age range

5 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Center of the University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. mean change in blood glucose

    Time frame: baseline to 1 hour

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

Secondary outcomes

  1. mean endogenous insulin secretion

    Time frame: baseline to 1 hour

    change in mean insulin collected at baseline and 1 hour post glucose challenge

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Formula - Understanding Nutrition (FUN)

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 23, 2020
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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