Healthy Term Infants Fed Milk-Based Formulas

Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

Study Overview

• Status: Completed
• Conditions: Healthy Term Infant
• Intervention / Treatment: Other: A powdered milk-based infant formula, standard fat blend; Other: Experimental powdered milk-based infant formula with an alternate fat blend

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infant is judged to be in good health.
• Infant is singleton from a full term birth
• Infant's birth weight was > 2490 g.
• Infant is between 53 and 115 days of age
• Infant is on infant formula and tolerating infant formula feedings
• Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
• Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria:

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Powdered milk-based formula, standard fat blend	Other: A powdered milk-based infant formula, standard fat blend; formula to be consumed ad lib
Experimental: Powder milk-based formula, alternate fat blend	Other: Experimental powdered milk-based infant formula with an alternate fat blend; formula to be consumed ad lib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calcium absorption	as measured in stool	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stool consistency	measured on 5 point scale	28 days
fat absorption	as measured in stool	8 days
average number of stools per day		28 days
percent of feedings with spit up/vomit associated with feeding per day.		28 days

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: John Lasekan, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: June 10, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 13, 2012

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 14, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: AK88