Baylor Infant Biomarker of Nutrition Study (BIBS)

September 11, 2024 updated by: Nancy Engelmann Moran, Baylor College of Medicine

Non-invasive Marker of Infant Food Intake

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 months to 9 months (Child)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Infants
Infants, 4-4.5 months of age at enrollment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of Skin Carotenoid Score Measurements- 4 Month Olds.
Time Frame: 1 day each

Time required to measure skin carotenoid score in 4 month olds. Units: seconds Scale: >0 seconds Interpretation: Lower numbers indicate faster, more favorable durations for measurements.

Range: 35-158 s
1 day each
Infant Plasma Carotenoid Concentration, 4 Months.
Time Frame: 1 day
Infant Plasma Total Carotenoid Concentration, 4 months.
1 day
Total Carotenoid Intake, 4 Month Olds
Time Frame: 7 days
Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary
7 days
Skin Carotenoid Scores in 4 Month Olds.
Time Frame: Measurements collected at the visit held when participants were 4 months of age.

Skin carotenoid scores in 4 month olds. Scale: 0-800 skin carotenoid score units. Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.

Range: 14-215
Measurements collected at the visit held when participants were 4 months of age.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.
Time Frame: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
Time Required for skin carotenoid score measurement, 6 and 8 month olds. Units: Seconds Scale: >0 Interpretation: Smaller durations indicate a more feasible, favorable duration Range: 37s - 133s
Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
Time Required for Skin Carotenoid Score Measurement, 6 and 8 Month Olds.
Time Frame: Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
Time Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds.
Measurements conducted at the study visit held at either 6 months of age of 8 months of age.
Skin Carotenoid Scores in 6 and 8 Month Olds.
Time Frame: Single day at either 6 months of age of 8 months of age.

Skin carotenoid scores in 6 and 8 month olds. Units: skin carotenoid score units on a scale Scale: 0-800 Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.

Range: 40-324
Single day at either 6 months of age of 8 months of age.
Skin Carotenoid Scores in 6 and 8 Month Olds
Time Frame: Single day at either 6 months of age of 8 months of age.

Skin carotenoid scores in 4 month olds. Unit: Skin Carotenoid Score Scale: 0-800 skin carotenoid score units Interpretation: Greater numbers indicate a greater, theoretically more favorable, skin carotenoid concentration than lower scores.

Range: 59-200
Single day at either 6 months of age of 8 months of age.
Daily Total Carotenoid Intake, 6 and 8 Month Olds
Time Frame: 7 days prior to the visits held at 6 months of age and at 8 months of age.
Total Carotenoid Intake per Day (average) Units: micrograms Scale: >0 micrograms Range: 100 - 7660
7 days prior to the visits held at 6 months of age and at 8 months of age.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin carotenoid measurement feasibility in 6 and 8 month olds.
Time Frame: 1 day
The time to acquire measurements at 6 and 8 months of age.
1 day
Skin carotenoid measurement reliability in 6 and 8 month olds.
Time Frame: 1 day
The intra-class correlation of repeated skin carotenoid measurements collected at 6 and 8 months of age.
1 day
Validity of skin carotenoid intensity as a correlate of total carotenoid intake at 6 and 8 months of age.
Time Frame: 1 day
The correlation between skin carotenoid intensity and with reported total carotenoid intake at 6 and 8 months of age.
1 day
Validity of skin carotenoid intensity as a correlate of plasma total carotenoids at 6 months.
Time Frame: 1 day
The correlation between skin carotenoid intensity and with total plasma carotenoid concentrations at 6 months of age.
1 day
Correlation between reported total carotenoid intake with plasma total carotenoid concentrations at 4 and 6 months of age.
Time Frame: 1 day
Correlation between reported total carotenoid intake with plasma total carotenoid concentrations at 4 and 6 months of age.
1 day
Correlation of plasma carotenoid species concentrations with blood lipoprotein cholesterol fractions at 4 months.
Time Frame: 1 day
Correlation of plasma carotenoid species concentrations with blood lipoprotein cholesterol fractions at 4 months.
1 day
Determinants of skin carotenoid and plasma carotenoid outcomes across 4, 6, 8 months of age.
Time Frame: 3 days
Generalized linear mixed model to test the significant determinants and interactions impacting skin carotenoid and plasma carotenoid outcomes across infancy.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor College of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nancy E. Moran, PhD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-43692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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