Healthy Infant NutritionBIBSNCT03996395

Baylor Infant Biomarker of Nutrition Study

An observational study of Healthy Infant Nutrition, run by Baylor College of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 4 to 9 monthsHealthy volunteers can take part
Conditions the study is for: Healthy Infant Nutrition
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 8 Apr 2019to 31 Dec 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 9 months
All sexes
Healthy volunteers accepted
Child

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.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Healthy Infant Nutrition
Keywords: infant, biomarker, fruit, vegetable, complementary feeding, nutrition, reflectance spectroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03996395
Study group	Role	What they receive
Infants		Infants, 4-4.5 months of age at enrollment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Time Required for Carotenoid Score Measurement, 6 and 8 Month Olds.
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
Measured: 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 Required for Heel Skin Carotenoid Score Measurement, 6 and 8 Month Olds.
Measured: 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.
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
Measured: Single day at either 6 months of age of 8 months of age.
Skin Carotenoid Scores in 6 and 8 Month Olds
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
Measured: Single day at either 6 months of age of 8 months of age.
Daily Total Carotenoid Intake, 6 and 8 Month Olds
Total Carotenoid Intake per Day (average) Units: micrograms Scale: >0 micrograms Range: 100 - 7660
Measured: 7 days prior to the visits held at 6 months of age and at 8 months of age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 201931 Dec 2020

First posted24 Jun 2019
Study start8 Apr 2019
Primary completion31 Dec 2020
Study completion31 Dec 2020

Why it stopped: The COVID-19 pandemic made the recruitment and follow-up of this study impractical.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy Infant NutritionStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03996395
Sponsor's protocol ID: H-43692
Acronym: BIBS
Status last verified: Sep 2024
First submitted: 21 Jun 2019
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Juneja S, Chang J, Nguyen T, Castaneda R, O'Connor TM, Musaad S, Moran NE. The relative validity of nutrition assessment methods for estimating infant carotenoid intake differs by assessment tool, nutrient database, and milk carotenoid adjustment method. Nutr Res. 2024 Aug;128:38-49. doi: 10.1016/j.nutres.2024.06.003. Epub 2024 Jun 13.
PubMed 39033693
Moran NE, Chang J, Stroh R, Zaidi Y, Hason N, Musaad S, O'Connor T. Noninvasive Reflection Spectroscopy Measurement of Skin Carotenoid Score in Infants Is Feasible and Reliable. J Nutr. 2023 Jan 14;152(12):2966-2977. doi: 10.1093/jn/nxac182.
PubMed 35981784

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Infant Nutrition trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Marker of Infant Food Intake
ClinicalTrials.gov ID: NCT03996395
Acronym / sponsor ID: BIBS / H-43692
Conditions: Healthy Infant Nutrition
Keywords: infant, biomarker, fruit, vegetable, complementary feeding, nutrition, reflectance spectroscopy
Study type: Observational
Recruitment status: TerminatedReason stopped: The COVID-19 pandemic made the recruitment and follow-up of this study impractical.
Enrolment: 21 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: 8 Apr 2019 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 24 Jun 2019 (actual)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Infants	–	–Infants, 4-4.5 months of age at enrollment

Who may qualify

Ages: 4 to 9 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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
Infant Plasma Carotenoid Concentration, 4 Months.
Time frame: 1 day
Infant Plasma Total Carotenoid Concentration, 4 months.
Total Carotenoid Intake, 4 Month Olds
Time frame: 7 days
Total Carotenoid Intake per day, 4 month olds, assessed by 7 day food diary
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

5 secondary outcomes

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.
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infants	21	9

Primary outcome: Duration of Skin Carotenoid Score Measurements- 4 Month Olds.

Time frame: 1 day each. Mean (Standard Deviation). Unit: seconds

Measure	Finger n = 21	Heel n = 21
Value	84 (31)	71 (23)

Heel: Descriptive statistic: 71

Primary outcome: Infant Plasma Carotenoid Concentration, 4 Months.

Time frame: 1 day. Mean (Standard Deviation). Unit: umol/L

Measure	4 Month Olds n = 11
Value	0.821 (0.412)

Population analysed: There are fewer blood samples than the total enrolled population due to some samples that could not be collected due to venipuncture difficulty and some families opting out of blood sampling.

Primary outcome: Total Carotenoid Intake, 4 Month Olds

Time frame: 7 days. Mean (Standard Deviation). Unit: ug/d

Measure	4 Month Olds n = 12
Value	225 (104)

Primary outcome: Skin Carotenoid Scores in 4 Month Olds.

Time frame: Measurements collected at the visit held when participants were 4 months of age.. Mean (Standard Deviation). Unit: skin carotenoid score units, 0-800 scale

Measure	Finger n = 21	Heel n = 21
Value	92.4 (56.6)	92.4 (51.4)

Population analysed: all enrolled participants attending the first visit

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infants	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Limitations and caveats (from the sponsor): The group sizes for this study were small, participants were recruited from only one geographic location in the US, there is an increase risk of type I error due to multiple testing, only infants with minimal solid food intake were eligible to enroll at 4 months, which may not be representative of the general 4 month old infant population.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 39033693Juneja S, Chang J, Nguyen T, Castaneda R, O'Connor TM, Musaad S, Moran NE. The relative validity of nutrition assessment methods for estimating infant carotenoid intake differs by assessment tool, nutrient database, and milk carotenoid adjustment method. Nutr Res. 2024 Aug;128:38-49. doi: 10.1016/j.nutres.2024.06.003. Epub 2024 Jun 13.
Results publication: PubMed 35981784Moran NE, Chang J, Stroh R, Zaidi Y, Hason N, Musaad S, O'Connor T. Noninvasive Reflection Spectroscopy Measurement of Skin Carotenoid Score in Infants Is Feasible and Reliable. J Nutr. 2023 Jan 14;152(12):2966-2977. doi: 10.1093/jn/nxac182.
Individual participant dataSharing planned: No

Related trials for Healthy Infant Nutrition

Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Not yet recruiting
Healthy Habits During and After Gestational Diabetes
GDM
RecruitingObservational study
Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy E. Moran, PhD principal investigator

Baylor College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Infant Nutrition, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Skin Carotenoid Score Measurements- 4 Month Olds. (time frame: 1 day each). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03996395, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.