AmyloidosisDRITANCT05738005
Dietary Reporting In The Amyloidoses
A study testing Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) in people with Amyloidosis, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis. The main question it aims to answer is: Is it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2023to 21 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosed with any type of amyloidosis
- Speak, read and write in English
- Willing to use the MyFitnessPal app on their own smartphone
Who cannot join
- a planned autologous stem cell transplant or a solid organ transplant in the 12 weeks after enrollment
- cognitive or perceptual disturbances
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Jeffrey Zonder, MD, 313-576-8732, zonderj@karmanos.org
Andrew Kin, M.D.
About this study
Official title: DRITA Pilot Trial: Dietary Reporting in the Amyloidoses
The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis.
The main question it aims to answer is:
Read more
Is it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients
Participants will be asked to:
- Download the MyFitnessPal application on their smartphone and view an online tutorial
- After a week of practice, from weeks 2-9, participants will enter daily dietary intake as well as daily herbal/alternative supplement intake into the MyFitnessPal application on their smartphone.
- complete a questionnaire prior to starting the application, after week 2 and at week 10 after starting the application
- Conditions
- Amyloidosis
- Being tested
- Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)Other
Amyloidosis patients will use MyFitnessPal application to track dietary intake and use of herbal/alternative supplements in from week 2-9. Patient's usage of the application and questionnaires completed by the patient at the start, Week 2 and Week 10 will determine feasibility.
| Study group | Role | What they receive |
|---|---|---|
| Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) | Other | MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements. Receives: Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rate
The adherence is defined by the status (yes vs. no) of data recording per day; The adherence rate will be calculated by the ratio of the number of days of adherence to the total number of days of trial (i.e., 56 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.
Measured: 56 days
Secondary outcomes (1)
Subsequent adherence rate
The subsequent adherence is the status of data recording per day during the third phase (Week 10) of trial participation (i.e., 7 days); The subsequent adherence rate will be calculated by the ratio of the number of days of adherence during the third phase (Week 10) of trial participation (i.e., 7 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.
Measured: 63 days (= 56 days + Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start2 Mar 2023
- Primary completion21 Nov 2027 (estimated)
- Study completion21 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute
- Investigators
- Jeffrey Zonder, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738005
- Sponsor's protocol ID
- 2022-067
- Acronym
- DRITA
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2023
- Last updated
- 26 Jun 2026
- Results posted
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRITA Pilot Trial: Dietary Reporting in the Amyloidoses
- ClinicalTrials.gov ID
- NCT05738005
- Acronym / sponsor ID
- DRITA / 2022-067
- Conditions
- Amyloidosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 21 Nov 2027 (estimated)
- Study completion
- 21 Nov 2028 (estimated)
- First posted
- 21 Feb 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.
The goal of this clinical trial is to learn about malnutrition and weight loss in patients with Amyloidosis.
The main question it aims to answer is:
Is it feasible to use a low-cost nutrition-based application (apps) for use on a smartphone to obtain detailed information on caloric intake in Amyloidosis patients
Participants will be asked to:
- Download the MyFitnessPal application on their smartphone and view an online tutorial
- After a week of practice, from weeks 2-9, participants will enter daily dietary intake as well as daily herbal/alternative supplement intake into the MyFitnessPal application on their smartphone.
- complete a questionnaire prior to starting the application, after week 2 and at week 10 after starting the application
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) | Other | Other: Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)MyFitnessPal smartphone application is used to track daily dietary intake and herbal/alternative supplements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Diagnosed with any type of amyloidosis
- Speak, read and write in English
- Willing to use the MyFitnessPal app on their own smartphone
Key exclusion criteria (2 listed)
- a planned autologous stem cell transplant or a solid organ transplant in the 12 weeks after enrollment
- cognitive or perceptual disturbances
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 |
|---|---|---|
| Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app)Amyloidosis patients will use MyFitnessPal application to track dietary intake and use of herbal/alternative supplements in from week 2-9. Patient's usage of the application and questionnaires completed by the patient at the start, Week 2 and Week 10 will determine feasibility. | Other | Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) |
Primary outcome
Adherence Rate
Time frame: 56 days
The adherence is defined by the status (yes vs. no) of data recording per day; The adherence rate will be calculated by the ratio of the number of days of adherence to the total number of days of trial (i.e., 56 days); The status of data recording per day will be considered 'yes' if the participant completes a daily survey.
1 secondary outcome
Subsequent adherence rate
Time frame: 63 days (= 56 days + Week 10)
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 26 Jun 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.
Jeffrey Zonder, MD principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracking Dietary/Supplement Intake on MyFitnessPal smartphone application (app) in people with Amyloidosis, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Jeffrey Zonder, MD (313-576-8732, zonderj@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Rate (time frame: 56 days). 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 26 Jun 2026.