MyRareDiet A Novel Diet Tracking Tool
NCT06664840 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-10-30
Summary
The investigators propose to develop and validate MyRareDiet® (MRD) to address an unmet need in the inborn errors of metabolism (IEM) population to assist with dietary management designed to increase adherence and compliance to treatment guidelines, while facilitating the collection of dietary data from individuals with IEM for research purposes.
Conditions
- Urea Cycle Disorder
- Propionic Aciduria
- Maple Syrup Urine Disease
- Methylmalonic Acidemia
Interventions
- OTHER
-
MDR diet assessment
Participants will record their dietary intake on the MyRareDiet (MRD) app and nutrient content will be assessed to validate MRD compared to a traditional interviewer assessed 24 hour recall.
- OTHER
-
24 hour recall
A trained nutritionist will conduct a telephone multi-pass 24 hour diet recall on 3 randomized nonconsecutive days. The dietary intake will be analyzed using NDSR and metabolic pro and nutrient intake will be compared to the nutrient intake assessed with the MRD app.
Sponsors & Collaborators
-
BrightOutcome
collaborator INDUSTRY -
National Urea Cycle Disorder Foundation
collaborator UNKNOWN -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Oregon Health and Science University
lead OTHER
Principal Investigators
-
Dershung Yang, PhD · BrightOutcomes, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 1 Year
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-15
- Primary Completion
- 2025-09-30
- Completion
- 2025-12-31
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