TerminatedNot Applicable

Baylor Infant Biomarker of Nutrition Study

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

United States21 participantsStarted 2019-04-08

Plain-language summary

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

Who can participate

Age range

4 Months – 9 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of Skin Carotenoid Score Measurements- 4 Month Olds.

Timeframe: 1 day each

Infant Plasma Carotenoid Concentration, 4 Months.

Timeframe: 1 day

Total Carotenoid Intake, 4 Month Olds

Timeframe: 7 days

Skin Carotenoid Scores in 4 Month Olds.

Timeframe: Measurements collected at the visit held when participants were 4 months of age.

Trial details

NCT IDNCT03996395

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

Results submitted2023-03-21

View on ClinicalTrials.gov More Healthy Infant Nutrition trials