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Effect of Infant Formula on Energy Balance (GRO)

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ClinicalTrials.gov Identifier: NCT01700205
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : September 16, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborators:
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Information provided by (Responsible Party):
Julie A. Mennella, PhD, Monell Chemical Senses Center

Brief Summary:
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 or disease Intervention/treatment Phase
Development Other: Type of Formula Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Between- and within-subject longitudinal trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Impact of Diet Composition on Energy Balance and Satiety During Infancy
Actual Study Start Date : November 2, 2012
Actual Primary Completion Date : March 17, 2016
Actual Study Completion Date : September 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Type of Formula: CMF
Infants are 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 (EHF)

Experimental: Type of Formula: EHF
Infants are 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 (EHF)




Primary Outcome Measures :
  1. Growth, Weight for Length (WLZ) Z Scores [ Time Frame: 0.5 to 12.5 months with followup visit at 18.5 mos ]
    At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).

  2. Growth, Weight for Age (WAZ) Z Score [ Time Frame: 0.5 to 12.5 months with followup visit at 18.5 mos ]
    At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).

  3. Growth: Length for Age (LAZ) Z Scores [ Time Frame: 0.5 to 12.5 months with followup visit at 18.5 mos ]
    At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).

  4. Energy Balance: Energy Intake From Infant Formula and Other Sources [ Time Frame: 0.75, 3.5, 12.5 mos ]
    Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days

  5. Energy Balance: Sleeping Energy Expenditure (SEE) [ Time Frame: 0.75, 3.5, 12.5 mos ]
    Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.

  6. Energy Balance: Total Energy Expenditure (TEE) [ Time Frame: 0.75, 3.5, 12.5 mos ]
    TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method

  7. Energy Balance: Energy Loss in Stools [ Time Frame: 0.75, 3.5, 12.5 mos ]
    Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint


Secondary Outcome Measures :
  1. Feeding Behaviors, Maternal Perceptions [ Time Frame: 0.5 months ]
    Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.



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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700205


Locations
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United States, Pennsylvania
Monell Chemical Senses Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Monell Chemical Senses Center
University of Delaware
Children's Hospital of Philadelphia
University of Wisconsin, Madison
Investigators
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Principal Investigator: Julie A Mennella, PhD Monell Chemical Senses Center
Principal Investigator: Jillian Trabulsi, PhD University of Delaware
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julie A. Mennella, PhD, Member, Monell Chemical Senses Center
ClinicalTrials.gov Identifier: NCT01700205    
Other Study ID Numbers: HD072307
First Posted: October 4, 2012    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Energy balance measures at 0.75, 3.5 and 12.5 months of age

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie A. Mennella, PhD, Monell Chemical Senses Center:
Formula Feeding
Mother
Moms
Infants
Babies
Baby
growth
energy balance