Effect of Infant Formula on Energy Balance

Development Clinical Trial

— GRO  

Official title:

Impact of Diet Composition on Energy Balance and Satiety During Infancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700205
• Other study ID #: HD072307
• Status: Completed
• Phase: N/A
• Start date: November 2, 2012
• Est. completion date: September 21, 2016

Study information

• Verified date: November 2019
• Source: Monell Chemical Senses Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 21, 2016
• Est. primary completion date: March 17, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Development

Intervention

Other:
• Type of Formula
infant formula

Locations

Country	Name	City	State
United States	Monell Chemical Senses Center	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Monell Chemical Senses Center	Children's Hospital of Philadelphia, University of Delaware, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (5)

Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. — View Citation

Mennella JA, Inamdar L, Pressman N, Schall JI, Papas MA, Schoeller D, Stallings VA, Trabulsi JC. Type of infant formula increases early weight gain and impacts energy balance: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):1015-1025. doi — View Citation

Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10. — View Citation

Mennella JA, Papas MA, Reiter AR, Stallings VA, Trabulsi JC. Early rapid weight gain among formula-fed infants: Impact of formula type and maternal feeding styles. Pediatr Obes. 2019 Jun;14(6):e12503. doi: 10.1111/ijpo.12503. Epub 2019 Jan 10. — View Citation

Mennella JA, Ventura AK, Beauchamp GK. Differential growth patterns among healthy infants fed protein hydrolysate or cow-milk formulas. Pediatrics. 2011 Jan;127(1):110-8. doi: 10.1542/peds.2010-1675. Epub 2010 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth, Weight for Length (WLZ) Z Scores	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).	0.5 to 12.5 months with followup visit at 18.5 mos
Primary	Growth, Weight for Age (WAZ) Z Score	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).	0.5 to 12.5 months with followup visit at 18.5 mos
Primary	Growth: Length for Age (LAZ) Z Scores	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).	0.5 to 12.5 months with followup visit at 18.5 mos
Primary	Energy Balance: Energy Intake From Infant Formula and Other Sources	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	0.75, 3.5, 12.5 mos
Primary	Energy Balance: Sleeping Energy Expenditure (SEE)	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.	0.75, 3.5, 12.5 mos
Primary	Energy Balance: Total Energy Expenditure (TEE)	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	0.75, 3.5, 12.5 mos
Primary	Energy Balance: Energy Loss in Stools	Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint	0.75, 3.5, 12.5 mos
Secondary	Feeding Behaviors, Maternal Perceptions	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.	0.5 months