Toddler Biomarker of Nutrition Study (TBONS)

Controlled Trial to Validate Skin Carotenoid Dietary Biomarker in Toddlers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nutrition, Healthy; Pediatric Nutrition
• Intervention / Treatment: Other: Applesauce Pouch; Other: Fruit-vegetable puree blend

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy E. Moran, PhD; Phone Number: 713-798-0520; Email: nancy.moran@bcm.edu
• Study Contact Backup: Name: Teresia M. O'Connor, MD, MPH; Phone Number: 713-798-6782; Email: teresiao@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo - 0 mg carotenoids / d; The placebo "0 mg/d" group consumes 1-90 g pouch of applesauce providing 0 mg carotenoids/d (Unsweetened Applesauce Pouches) daily for 4 weeks.	Other: Applesauce Pouch; 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.
Experimental: Low - 2.5 mg carotenoids / d; The low "2.5 mg/d" group will consume alternating pouches of the applesauce (0 mg carotenoids/90 g pouch) and a 120 g pouch of fruit-vegetable puree blend providing 5 mg mixed carotenoids (Carrot, Banana, Mango, & Sweet Potato pouch) daily for 4 weeks.	Other: Applesauce Pouch; 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.; Other: Fruit-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.; Other Names: Carrot, Banana, Mango, & Sweet Potato pouch, Happy Tot, Happy Family Brands
Experimental: High - 5 mg carotenoids / d; The high dose "5 mg/d" group will be provided one 120 g pouch/day of the fruit-vegetable puree blend (Carrot, Banana, Mango, & Sweet Potato pouch) daily for 4 weeks.	Other: Fruit-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.; Other Names: Carrot, Banana, Mango, & Sweet Potato pouch, Happy Tot, Happy Family Brands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline dietary carotenoid intake at 4 weeks	Dietary carotenoid intake assessed by 3-day food diary	Four weeks
Intervention adherence	Amount of the intervention foods consumed daily, recorded by adult guardians.	Daily from baseline to end of study (4 weeks)

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Houston; East Carolina University
• Investigators: Principal Investigator: Nancy E. Moran, PhD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2025
• Primary Completion (Anticipated): February 28, 2027
• Study Completion (Anticipated): April 30, 2028

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: nutrition assessment; fruits and vegetables; carotenoids; nutritional biomarkers; pediatric nutrition; skin carotenoids
• Other Study ID Numbers: H-53006; 1R01HD111555 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No