MyRareDiet A Novel Diet Tracking Tool
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-80
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with urea cycle disorder, propionic acidemia, maple syrup urine disease or methylmalonic acidemia
consuming a diet where ≥50% of energy is supplied by foods consumed orally
self-known (or prescribed) dietary energy goal and protein restriction
internet connected device to access MyRareDiet
Disqualifiers
pregnant
Trial design
Design model
Crossover
Treatments tested in this trial
MDR diet assessment
Other interventionParticipants 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.
24 hour recall
Other interventionA 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MyRareDietExperimental treatment 1 intervention
Group B: 24 hour recallActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Energy
Total reported energy intake
Time frame
24 hour2
Protein
Total percent of calories from protein
Time frame
24 hourSecondary outcomes
1
Carbohydrate
total percent of calories from carbohydrate
Time frame
24 hour2
Fat
Total percent of calories from Fat
Time frame
24 hourLocations
Sponsors and contacts
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Oregon Health and Science University
Lead sponsor
BrightOutcome
Collaborator
National Urea Cycle Disorder Foundation
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov
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