NCT05855824

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
3.1 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

April 25, 2023

Last Update Submit

March 24, 2026

Conditions

Pediatric NutritionNutrition, Healthy

Keywords

carotenoidsnutritional biomarkersnutrition assessmentpediatric nutritionskin carotenoidsfruits and vegetables

Outcome Measures

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.

    Four weeks

Secondary Outcomes (1)

  • Change from baseline serum carotenoid concentration at 4 weeks

    Four weeks

Other Outcomes (2)

  • Change from baseline dietary carotenoid intake at 4 weeks

    Four weeks

  • Intervention adherence

    Daily from baseline to end of study (4 weeks)

Study Arms (3)

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.

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.

Other: Applesauce PouchOther: 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.

Other: Fruit-vegetable puree blend

Interventions

Applesauce PouchOTHER

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

Also known as: Unsweetened Applesauce Pouches, Mott's Inc.
Low - 2.5 mg carotenoids / dPlacebo - 0 mg carotenoids / d
Fruit-vegetable puree blendOTHER

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.

Also known as: Carrot, Banana, Mango, & Sweet Potato pouch, Happy Tot, Happy Family Brands
High - 5 mg carotenoids / dLow - 2.5 mg carotenoids / d

Eligibility Criteria

Age24 Months - 26 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mangifera indica extract

Study Officials

  • Nancy E. Moran, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy E. Moran, PhD

CONTACT

713-798-0520Nancy.Moran@bcm.edu

Teresia M. O'Connor, MD, MPH

CONTACT

713-798-6782teresiao@bcm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomized to a low, medium, or high carotenoid food intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 12, 2023

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share