Pediatric NutritionTBONSNCT05855824
Toddler Biomarker of Nutrition Study
A study testing Applesauce Pouch and Fruit-vegetable puree blend in people with Pediatric Nutrition and Nutrition, Healthy, run by Baylor College of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 26 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Nutrition, Nutrition, Healthy
- What is being tested?
- Applesauce Pouch and Fruit-vegetable puree blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 26 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Nutrition, Nutrition, Healthy
- Being tested
- Applesauce Pouch, Fruit-vegetable puree blend
- Keywords
- carotenoids, nutritional biomarkers, nutrition assessment, pediatric nutrition, skin carotenoids, fruits and vegetables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applesauce PouchOther
Also called Unsweetened Applesauce Pouches, Mott's Inc.
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 blendOther
Also called Carrot, Banana, Mango, & Sweet Potato pouch, Happy Tot, Happy Family Brands
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo - 0 mg carotenoids / d | Placebo comparator | 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. Receives: Other: Applesauce Pouch |
| Low - 2.5 mg carotenoids / d | Experimental | 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. Receives: Other: Applesauce Pouch; Other: Fruit-vegetable puree blend |
| High - 5 mg carotenoids / d | Experimental | 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. Receives: Other: Fruit-vegetable puree blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start30 Oct 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric NutritionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to a low, medium, or high carotenoid food intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, East Carolina University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nancy Engelmann Moran, Baylor College of Medicine
- Investigators
- Nancy E. Moran, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855824
- Sponsor's protocol ID
- H-53006
- Other IDs
- 1R01HD111555
- Acronym
- TBONS
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Trial to Validate Skin Carotenoid Dietary Biomarker in Toddlers
- ClinicalTrials.gov ID
- NCT05855824
- Acronym / sponsor ID
- TBONS / H-53006
- Conditions
- Pediatric Nutrition, Nutrition, Healthy
- Keywords
- carotenoids, nutritional biomarkers, nutrition assessment, pediatric nutrition, skin carotenoids, fruits and vegetables
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Houston, East Carolina University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to a low, medium, or high carotenoid food intervention.
| Arm | Type | Receives |
|---|---|---|
| Placebo - 0 mg carotenoids / d | Placebo comparator | Other: Applesauce PouchThe placebo "0 mg/d" group consumes 1-90 g pouch of applesauce providing 0 mg carotenoids/d (Unsweetened Applesauce Pouches) daily for 4 weeks. |
| Low - 2.5 mg carotenoids / d | Experimental | Other: Applesauce Pouch, Other: Fruit-vegetable puree blendThe 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. |
| High - 5 mg carotenoids / d | Experimental | Other: Fruit-vegetable puree blendThe 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. |
Who may qualify
- Ages
- 24 to 26 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applesauce PouchAlso: Unsweetened Applesauce Pouches, Mott's Inc.One 90 g pouch of applesauce provides 0 mg carotenoids/d and 40 kcal, 10 mg vitamin C, and 1 g dietary fiber. | Other | Low - 2.5 mg carotenoids / d, Placebo - 0 mg carotenoids / d |
| Fruit-vegetable puree blendAlso: Carrot, Banana, Mango, & Sweet Potato pouch, Happy Tot, Happy Family BrandsOne 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 | High - 5 mg carotenoids / d, Low - 2.5 mg carotenoids / d |
Primary outcome
Change from baseline skin carotenoid concentration at 4 weeks
Time frame: Four weeks
Change in pressure mediated reflection spectroscopy measurement of total carotenoids at the finger over 4 weeks.
1 secondary outcome
Change from baseline serum carotenoid concentration at 4 weeks
Time frame: Four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nancy E. Moran, PhD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Applesauce Pouch and Fruit-vegetable puree blend in people with Pediatric Nutrition and Nutrition, Healthy, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy E. Moran, PhD (713-798-0520, Nancy.Moran@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline skin carotenoid concentration at 4 weeks (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.