Nutrition, Healthy, Pediatric Nutrition
Conditions
Keywords
carotenoids, nutritional biomarkers, nutrition assessment, pediatric nutrition, skin carotenoids, fruits and vegetables
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.
Interventions
OTHERApplesauce Pouch
One 90 g pouch of applesauce provides 0 mg carotenoids/d and 40 kcal, 10 mg vitamin C, and 1 g dietary fiber.
OTHERFruit-vegetable puree blend
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.
Sponsors
Baylor College of Medicine
University of Houston
East Carolina University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The investigator and statisticians on the team will be blinded. A staff member outside of the team will be responsible for randomly assigning and dispensing the study foods.
Intervention model description
Participants will be randomized to a low, medium, or high carotenoid food intervention.
Eligibility
Sex/Gender
ALL
Age
24 Months to 26 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline skin carotenoid concentration at 4 weeks | Four weeks | Change in pressure mediated reflection spectroscopy measurement of total carotenoids at the finger over 4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline serum carotenoid concentration at 4 weeks | Four weeks | Total plasma carotenoids (sum of beta-carotene, alpha-carotene, lutein, zeaxanthin, lycopene, and beta-cryptoxanthin) in participant plasma. |
Contacts
CONTACTNancy E. Moran, PhD
CONTACTTeresia M. O'Connor, MD, MPH
PRINCIPAL_INVESTIGATORNancy E. Moran, PhD
Baylor College of Medicine
Outcome results
None listed