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BabyEE Pilot: Measurement of Energy Metabolism in Infants

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02683473
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
40
Enrollment
1
Location
81
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. The overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) and physical activity. This cross-sectional study will answer the following questions:

    1. What is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart?

    2. What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?

    3. How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Measurement of Energy Metabolism in Infants: BabyEE Pilot
    Actual Study Start Date :
    Mar 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Infants

    Infants aged 1-3 months

    Outcome Measures

    Primary Outcome Measures

    1. Energy Expenditure by infant metabolic chamber [Approximately 1 week]

      Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.

    2. Energy expenditure by doubly labeled water [Approximately 1 week]

      Energy expenditure by doubly labeled water measured over 7 days in infants aged 1-3 months

    Secondary Outcome Measures

    1. Percent body fat [Approximately 1 week]

      Percent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.

    2. Physical activity counts [Approximately 1 week]

      Physical activity counts by Actigraph accelerometer measured over 7 days in infants aged 1-3 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 3 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy, full-term infant

    • Aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit

    • Exclusively fed breast milk and/or infant formula

    • Willing to accept doubly-labeled water

    • If breastfed, willing to accept pumped breast milk for some of the study procedures

    Exclusion Criteria:

    • Unable to complete 2 assessment visits 5-7 days apart at Pennington Biomedical Research Center

    • Unable or unwilling to eat from an infant feeding bottle

    • Born preterm (< 37 weeks gestation)

    • Congenital abnormality or disability

    • Gastric reflux

    • Acute illness within 7 days of the study (fever, diarrhea)

    • Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT02683473
    Other Study ID Numbers:
    • PBRC 2015-061
    • P30DK072476-10
    First Posted:
    Feb 17, 2016
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Overnutrition
    Infant Nutrition Disorders

    Study Results

    No Results Posted as of Jun 9, 2022