The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase (NUTRIENT)
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|ClinicalTrials.gov Identifier: NCT03907436|
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myeloproliferative Disorder Myeloproliferative Syndrome Myelofibrosis Polycythemia Vera Essential Thrombocythemia||Other: USDA Diet Other: Mediterranean Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to one of two healthy diets (USDA or Mediterranean diet)|
|Masking Description:||Participants will not be told which diet arm they are randomized to. Participants will not be told the two options are USDA or Mediterranean, only there are two "healthy" diets.|
|Official Title:||The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||October 1, 2019|
|Actual Study Completion Date :||October 1, 2019|
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.
Other: USDA Diet
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.
Other: Mediterranean Diet
Participants will receive counseling and education on a Mediterranean diet.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907436
|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92617|
|Principal Investigator:||Angela G Fleischman, MD PhD||University of California, Irvine|