Health TrialsbyHealthPanel

Toddler Biomarker of Nutrition Study

ConditionsPediatric NutritionNutrition, Healthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-26
SponsorBaylor College of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Applesauce Pouch

    Other intervention

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

  • Fruit-vegetable puree blend

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Placebo - 0 mg carotenoids / dPlacebo comparator 1 intervention
Group B: Low - 2.5 mg carotenoids / dExperimental treatment 2 interventions
Group C: High - 5 mg carotenoids / dExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline skin carotenoid concentration at 4 weeks

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

Time frame
Four weeks

Secondary outcomes

1

Change from baseline serum carotenoid concentration at 4 weeks

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

Time frame
Four weeks

Other outcomes

1

Change from baseline dietary carotenoid intake at 4 weeks

Dietary carotenoid intake assessed by 3-day food diary

Time frame
Four weeks
2

Intervention adherence

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

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

University of Houston

Collaborator

East Carolina University

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: