Clinical trial NCT05855824: Toddler Biomarker of Nutrition Study
Official title: Controlled Trial to Validate Skin Carotenoid Dietary Biomarker in Toddlers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Nutrition
Nutrition, Healthy
Keywords: carotenoids
nutritional biomarkers
nutrition assessment
pediatric nutrition
skin carotenoids
fruits and vegetables
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Houston
name: East Carolina University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-12
Enrollment: 150
Sex: ALL
Minimum age (years): 24
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to a low, medium, or high carotenoid food intervention.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline skin carotenoid concentration at 4 weeks
timeFrame: Four weeks
Secondary outcomes:
measure: Change from baseline serum carotenoid concentration at 4 weeks
timeFrame: Four weeks
Other outcomes:
measure: Change from baseline dietary carotenoid intake at 4 weeks
timeFrame: Four weeks
measure: Intervention adherence
timeFrame: Daily from baseline to end of study (4 weeks)
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Nancy E. Moran, PhD
role: PRINCIPAL_INVESTIGATOR
References: