Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Baylor Infant Biomarker of Nutrition Study (BIBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996395
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nancy Engelmann Moran, Baylor College of Medicine

Brief Summary:
The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.

Condition or disease
Healthy Infant Nutrition

Detailed Description:

RATIONALE: During infancy, children go from consuming primarily breast milk or formula, to consuming a variety of baby foods and table foods. Doctors, researchers, and community health workers are interested in knowing what foods infants eat, but since many infants have multiple adult caregivers, it can be hard for one caregiver to accurately recall the dietary pattern of the infant. A rapid, non-invasive biomarker of food intake in infants could serve as a useful monitoring tool.

PURPOSE: In order to develop a non-invasive measure of infant food intake, the association between infant dietary patterns, skin carotenoids, and blood carotenoids will be evaluated at 4, 6, and 8 months of age.

OUTLINE: Infants will visit the research center at 4, 6, and 8 months of age for length, weight, skinfold thickness, and skin colorant measures. An infant blood sample will be collected at each visit and lactating mothers will be asked to provide a breast milk sample. The caregiver will complete a food survey at each visit, will keep an infant food diary for a week at 4, 6, and 8 months of age, and will enter the food diaries into an online survey 3 times during each of the diary weeks.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Marker of Infant Food Intake
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Infants
Infants, 4-4.5 months of age at enrollment



Primary Outcome Measures :
  1. Skin carotenoid intensity at 8 months of age. [ Time Frame: 1 day ]
    Skin carotenoid intensity measured by pressure-mediated reflectance spectroscopy will be determined at the infant heel and finger.


Secondary Outcome Measures :
  1. Skin carotenoid intensity at 6 months of age. [ Time Frame: 1 day ]
    Skin carotenoid intensity measured by pressure-mediated reflectance spectroscopy will be determined at the infant heel and finger.

  2. Skin carotenoid intensity at 4 months of age. [ Time Frame: 1 day ]
    Skin carotenoid intensity measured by pressure-mediated reflectance spectroscopy will be determined at the infant heel and finger.

  3. Change in skin carotenoid intensity between 4 and 6 months of age. [ Time Frame: 2 months between 2 measurements ]
    Skin carotenoid intensity measured by pressure-mediated reflectance spectroscopy will be determined at the infant heel and finger.

  4. Change in skin carotenoid intensity between 6 and 8 months of age. [ Time Frame: 2 months between 2 measurements ]
    Skin carotenoid intensity measured by pressure-mediated reflectance spectroscopy will be determined at the infant heel and finger.


Other Outcome Measures:
  1. Plasma carotenoid concentration at 4 months of age. [ Time Frame: 1 day ]
    Plasma total carotenoid concentrations will be measured for a blood sample collected at the 4 month visit.

  2. Plasma carotenoid concentration at 6 months of age. [ Time Frame: 1 day ]
    Plasma total carotenoid concentrations will be measured for a blood sample collected at the 6 month visit.

  3. Plasma carotenoid concentration at 8 months of age. [ Time Frame: 1 day ]
    Plasma total carotenoid concentrations will be measured for a blood sample collected at the 8 month visit.


Biospecimen Retention:   Samples Without DNA
blood plasma from infant, breast milk from lactating mother if applicable


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited using the CNRC and BCM clinical study recruitment websites and listservs, the CNRC volunteer database, word of mouth, and approved flyers posted on the BCM campus, the Texas Children's Health Plan Center for Women and Children clinics, the Texas Children's Hospital/Baylor College of Medicine (TCH/BCM) pediatric clinics, and the TCH/BCM obstetrics and gynecology clinics. We will also distribute flyers in-person (pending the permission of the clinic) in the waiting rooms of the TCH/BCM pediatrics and Texas Children's Health Plan Clinic and at sites throughout the community.
Criteria

Inclusion Criteria:

  • 4-4.5 months old at baseline
  • born at term (>/=37 weeks gestation)
  • within the 5th-95th weight-for-age percentile (inclusive)
  • primary caregiver can speak, read, and understand English
  • infants are exclusively breast- and/or formula-feeding at baseline
  • consenting parent or caregiver must be 18 years old or older

Exclusion Criteria:

  • has a sibling enrolled in the study
  • metabolic, digestive, or malabsorptive disorders
  • known bleeding or clotting disorder
  • requires a special diet
  • exposed to tobacco smoke in the home
  • currently taking any isolated carotenoid supplements
  • using medications or complementary or alternative medications that interfere with dietary fat absorption
  • has a history of endocrine disorders requiring hormone administration.

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): NCT03996395


Contacts
Layout table for location contacts
Contact: Nancy E. Moran, PhD 713-798-0520 Nancy.Moran@bcm.edu
Contact: Jocelyn Chang, MS 713-798-0517 Jocelyn.Chang@bcm.edu

Locations
Layout table for location information
United States, Texas
USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Nancy E. Moran, PhD    713-798-0520    nancy.moran@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Nancy E. Moran, PhD Baylor College of Medicine
Layout table for additonal information
Responsible Party: Nancy Engelmann Moran, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03996395    
Other Study ID Numbers: H-43692
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nancy Engelmann Moran, Baylor College of Medicine:
infant
biomarker
fruit
vegetable
complementary feeding
nutrition
reflectance spectroscopy