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NCT Number: NCT05855824

Toddler Biomarker of Nutrition Study

This is a study of how accurate different methods to assess young children's dietary intake are, so that researchers and health professionals can better understand how children's nutrition relates to their health. The study will compare food surveys, measurements of nutrients in the blood, and optical measurements of nutrients in the skin.

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Key information

Age range

24 month–26 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Young children rely on their foods and drinks for the nutrients they need to grow, like energy, protein, vitamins, and minerals. However, it is challenging for researchers to study children's nutrition, because it is difficult to rapidly and accurately assess what exactly children eat. This is a study of different methods to assess young children's dietary intake so that researchers can better understand how children's nutrition relates to their health. The study will compare food surveys, measurements of nutrients in the blood, and optical measurements of nutrients in the skin to see how well these different measures agree with one another.

Carotenoids are a group of natural red, orange, and yellow substances found in fruits and vegetables. Children and adults absorb carotenoids from their foods. Measurements of the amounts of carotenoids in blood or optically in the skin can serve as to indirectly measure what a person eats. Optical skin carotenoid measurements could be a simple alternative to blood sampling or dietary surveys for researchers and practitioners in medicine and public health to quickly assess children's diets. What is unknown is how long it takes for blood or skin carotenoid measurements in young children to change in response to a change in their diet. Also, how accurately the blood and skin carotenoid measurements reflect the changes in a child's diet is unknown.

For this research study, volunteers to report on what their child eats over the course of 4 weeks. Participants will also incorporate specific fruit and/or fruit and vegetable blended puree pouches into their toddler's daily eating pattern. The study will follow how quickly the skin and blood measurements change in response to specific changes to the child participant's eating patterns. The study involves 3 visits and consuming a study-provided food every day for 4 weeks. At each visit, parents will report on the participating child's recent eating pattern, the study team will measure the child participant's body size and skin fold thicknesses as a measure of body composition, collect a blood sample (1 teaspoon), and do optical measurements of their skin. At visit 1, child participants will be randomly assigned to consume a daily applesauce pouch, or a carrot-mango-banana-sweet potato pouch, or alternate between the two pouches, for the next 4 weeks. The adult guardian and the child participants then return at 14 and 28 days. Before the last two visits, the adult participant will complete online surveys about what their child has been eating.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • 24 months of age
  • categorized by their guardian caregiver as either non-Hispanic white, Asian, Hispanic white, or non-Hispanic Black
  • participating guardian speaks, reads, and understands English.

Exclusion criteria

  • metabolic, endocrine, or digestive condition, food intolerance, or food allergy
  • bleeding or clotting disorder
  • taking a medication or complementary alternative medicine that would interfere with fat absorption
  • taking a dietary supplement that provided more than 1 mg carotenoids per day
  • has a sibling that is participating or participated in the study.

Treatment and study plan

Applesauce Pouch

Other

One 90 g pouch of applesauce provides 0 mg carotenoids/d and 40 kcal, 10 mg vitamin C, and 1 g dietary fiber.

Other names: Unsweetened Applesauce Pouches, Mott's Inc.

Fruit-vegetable puree blend

Other

One 120 g pouch of fruit-vegetable puree blend provides 5 mg mixed carotenoids, 70 kcal, 4 mg vitamin C, and 2 g dietary fiber.

Other names: Carrot, Banana, Mango, & Sweet Potato pouch, Happy Tot, Happy Family Brands

Primary outcomes

  1. Change from baseline skin carotenoid concentration at 4 weeks

    Time frame: Four weeks

    Change in pressure mediated reflection spectroscopy measurement of total carotenoids at the finger over 4 weeks.

Secondary outcomes

  1. Change from baseline serum carotenoid concentration at 4 weeks

    Time frame: Four weeks

    Total plasma carotenoids (sum of beta-carotene, alpha-carotene, lutein, zeaxanthin, lycopene, and beta-cryptoxanthin) in participant plasma.

Other outcomes

  1. Change from baseline dietary carotenoid intake at 4 weeks

    Time frame: Four weeks

    Dietary carotenoid intake assessed by 3-day food diary

  2. Intervention adherence

    Time frame: Daily from baseline to end of study (4 weeks)

    Amount of the intervention foods consumed daily, recorded by adult guardians.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy E. Moran, PhD

CONTACT

[email protected]

713-798-0520

Teresia M. O'Connor, MD, MPH

CONTACT

[email protected]

713-798-6782

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • East Carolina University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Houston

Registry information

Official study title

Controlled Trial to Validate Skin Carotenoid Dietary Biomarker in Toddlers

Acronym: TBONS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 12, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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