- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907436
The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase (NUTRIENT)
March 23, 2020 updated by: Angela G. Fleischman, University of California, Irvine
The purpose of this study is to determine whether MPN patient are able to adhere to a dietary intervention.
Participants will be randomized to one of two healthy diets.
Participants will receive in person dietician counseling and online curriculum.
Adherence will be measured using online surveys and phone diet recalls.
Changes in inflammatory markers in blood will also be measured at 5 time points during this 15 week study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a 15 week study, including 10 weeks of active diet intervention.
Each participant will receive one dietician counseling session at the beginning of the diet intervention period, two brief follow up dietician phone calls, and 10 diet education handouts delivered via email each week.
The main objective of this protocol is to test whether MPN patients can adhere to a diet intervention.
The investigators will measure adherence in both arms with patient reported diet recall every two weeks via internet surveys.
As exploratory endpoints the investigators will measure changes in inflammatory markers, symptom burden, physical activity level, sleep, and gut microbiome in participants over the course of the study.
If successful, the investigators plan to use this intervention in a larger trial to assess whether a diet intervention can effectively change symptom burden and inflammation in MPN patients.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92617
- University of California, Irvine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least 18 years old
- Diagnosis of Myeloproliferative Neoplasm (MPN) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), or Myelofibrosis (MF)
- Any type of previous therapy is allowed
- ECOG performance status ≤2
- Life expectancy of greater than 20 weeks
- Has an email address and can access the internet
- Able to read and understand English
Exclusion Criteria:
- Children
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: USDA diet arm
Participants will receive dietician counseling based on the USDA guidelines for Americans, 2010.
Participants will receive 10 weekly pdf handouts via email with information pertaining to these diet recommendations.
Participants will receive same surveys (including 14 point Mediterranean diet adherence score), 24 hour diet recalls, and biological sample draws at the Mediterranean arm.
|
Participants will receive counseling and education on USDA Guidelines for Americans, 2010
|
Experimental: Mediterranean diet arm
Participants will receive dietician counseling on a standard Mediterranean diet although they will not be told this diet is labelled as a Mediterranean diet.
Participants will receive 10 weekly pdf handouts via email with information pertaining to these diet recommendations.
Participants will receive same surveys (including 14 point Mediterranean diet adherence score), 24 hour diet recalls, and biological sample draws at the USDA diet arm.
|
Participants will receive counseling and education on a Mediterranean diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
14-point Mediterranean Diet Adherence Screener (MEDAS)
Time Frame: 15 weeks
|
14 question survey assessing adherence to a Mediterranean diet.
This is a 14 question survey, with possible 1 point per question.
A perfect adherence to a Mediterranean Diet is 14 on this survey (min 0 max 14).
Higher values represent closer adherence to a Mediterranean diet.
|
15 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
Time Frame: 15 weeks
|
MPN Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) score, a validated measure for quantifying symptom burden in MPN.
This is a 10 item survey, with each question answered on a scale of 0 to 10.
The minimum score is 0, the maximum score is 100.
Higher numbers mean a higher symptom burden.
|
15 weeks
|
Inflammatory cytokines
Time Frame: 15 weeks
|
Measurement of inflammatory cytokines in the plasma.
This includes EGF, Eotaxin, FGF-basic, G-CSF, GM-CSF, HGF, IFN-alpha, IFN-gamma, IL-1 beta, IL-1 alpha, IL-1RA, IL-2, IL-2R, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40/p70) IL-13, IL-15, IL-17A, IL-17F, IL-22, IP-10, MCP-1, MIG, MIP-1 alpha, MIP-1 beta, RANTES, TNF-alpha, VEGF.
|
15 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angela G Fleischman, MD PhD, University of California, Irvine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
April 2, 2019
First Submitted That Met QC Criteria
April 4, 2019
First Posted (Actual)
April 9, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-4521
- 18-30 (Other Identifier: Chao Family Comprehensive Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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