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"Watch Your Baby Grow" Study (GRO)

This study is currently recruiting participants.
Verified April 2013 by Monell Chemical Senses Center
Sponsor:
Collaborators:
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Information provided by (Responsible Party):
Julie A. Mennella, Monell Chemical Senses Center
ClinicalTrials.gov Identifier:
NCT01700205
First received: October 2, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.


Condition Intervention
Growth
Energy Balance
 Other: Type of Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title: Impact of Diet Composition on Energy Balance and Satiety During Infancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Monell Chemical Senses Center:

Primary Outcome Measures:
  • Growth and energy balance [ Time Frame: Infant age 2 weeks to 18 months ] [ Designated as safety issue: No ]
    Anthropometry z-scores (weight for age, length for age, head circumference for age, weight for length) obtained during monthly assessments for first 18 mos of life. All components of energy balance measured at 0.5, 3, and 12 months


Secondary Outcome Measures:
  • Intake and feeding behaviors [ Time Frame: Infant age 2 weeks to 18 months ] [ Designated as safety issue: No ]
    Intake and satiety behaviors measured during infant-led feeding conditions. Maternal reports of infant dietary history and maternal perception of infant behavior, using standardized questionnaires, will also be obtained.

  • Genotype [ Time Frame: 2wks-18 months ] [ Designated as safety issue: No ]
    Saliva and stool samples will be collected and later genotyped.


Estimated Enrollment: 144
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Type of Formula: CMF
infant is randomized to feed standard cow milk formula during first year of life
 Other: Type of Formula
infant formula
Other Names:
  • cow milk formula (CMF)
  • protein hydrolysate formula (ePHF)
Experimental: Type of Formula: ePHF
infant is randomized to feed extensively hydrolyzed infant formula during first year of life
 Other: Type of Formula
infant formula
Other Names:
  • cow milk formula (CMF)
  • protein hydrolysate formula (ePHF)

Detailed Description:

This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.

  Eligibility

Ages Eligible for Study:   up to 3 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.
  2. Birth weight between 2500 - 4500 grams.
  3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).
  4. Mother must be 18 years or older.
  5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.

Exclusion Criteria

  1. Mother had gestational diabetes during pregnancy
  2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.
  3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).
  4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).
  5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.
  6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700205

Contacts
Contact: Julie A Mennella, PhD 267-519-4880 mennella@monell.org
Contact: Loma Inamdar, BS 267-519-4896 linamdar@monell.org

Locations
United States, Pennsylvania
Monell Chemical Senses Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Loma Inamdar, MS     267-519-4896     linamdar@monell.org    
Contact: Julie A Mennella, PhD     267-519-4880     mennella@monell.org    
Principal Investigator: Julie A Mennella, PhD            
Sub-Investigator: Loma B Inamdar, BS            
Sponsors and Collaborators
Monell Chemical Senses Center
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Investigators
Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Jillian Trabulsi, PhD University of Delaware
  More Information

Publications:

Responsible Party: Julie A. Mennella, Member, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT01700205     History of Changes
Other Study ID Numbers: HD072307
Study First Received: October 2, 2012
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Monell Chemical Senses Center:
Formula Feeding
Mother
Moms
Infants
 Babies
Baby
growth
energy balance

ClinicalTrials.gov processed this record on May 22, 2013