Toddler Biomarker of Nutrition Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pediatric Nutrition Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to a low, medium, or high carotenoid food intervention.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Applesauce Pouch

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Applesauce Pouch

Intervention Type OTHER

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

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Fruit-vegetable puree blend

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Unsweetened Applesauce Pouches, Mott's Inc. Carrot, Banana, Mango, & Sweet Potato pouch, Happy Tot, Happy Family Brands

Eligibility Criteria

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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.

Minimum Eligible Age

24 Months

Maximum Eligible Age

26 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes