MyRareDiet A Novel Diet Tracking Tool

NCT06664840 | Not Yet Recruiting

• 1 other identifier: 1R44HD107766
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Energy

  Total reported energy intake

  24 hour

• Protein

  Total percent of calories from protein

  24 hour

Secondary Outcomes (2)

• Carbohydrate

  24 hour

• Fat

  24 hour

Study Arms (2)

MyRareDiet

EXPERIMENTAL

MyRareDiet (MRD) entries: Participants will enter their dietary intake into the MyRareDiet app on a series of three random nonconsecutive days. Participants will receive reminders from both OHSU bionutritionist (via email, phone, or text) and from the MRD system to record their dietary intake on the MRD app for particular randomized days.

Other: MDR diet assessment

24 hour recall

ACTIVE COMPARATOR

24-hour diet recalls: A series of three randomized nonconsecutive days of 24-hour food recall interviews by telephone will be completed by trained OHSU Bionutrition personnel to determine nutrient intake. Dietary intake will be evaluated with on Nutrition Data System for Research (NDSR) and Metabolic Pro nutrient databases.

Other: 24 hour recall

Interventions

MDR diet assessment OTHER

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.

MyRareDiet

24 hour recall OTHER

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.

24 hour recall

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant

Sponsors & Collaborators

• Oregon Health and Science University: lead
• BrightOutcome: collaborator
• National Urea Cycle Disorder Foundation: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

MeSH Terms

Conditions

Urea Cycle Disorders, Inborn; Propionic Acidemia; Maple Syrup Urine Disease; Methylmalonic acidemia

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dershung Yang, PhD

  BrightOutcomes, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie B Gillingham, PhD

CONTACT

503-494-1682; gillingm@ohsu.edu

Angela Horgan, PhD

CONTACT

503-494-6231; horgana@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is to conduct a validity study to test the agreement between MyRareDiet and the validated interview-based 24-hour diet recall method used in the National Health and Nutrition Examination Survey (NHANES).

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 30, 2024
• Study Start: November 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share