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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
Sponsor:
Information provided by (Responsible Party):
Angela G. Fleischman, University of California, Irvine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myeloproliferative Disorder Myeloproliferative Syndrome Myelofibrosis Polycythemia Vera Essential Thrombocythemia Other: USDA Diet Other: Mediterranean Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of two healthy diets (USDA or Mediterranean diet)
Masking: Single (Participant)
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.
Primary Purpose: Treatment
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


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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92617
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Angela G Fleischman, MD PhD University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Angela G. Fleischman, University of California, Irvine:
Informed Consent Form  [PDF] August 27, 2018

Additional Information:
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Responsible Party: Angela G. Fleischman, Assistant Professor, Division of Hematology/Oncology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03907436    
Other Study ID Numbers: 2018-4521
18-30 ( Other Identifier: Chao Family Comprehensive Cancer Center )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angela G. Fleischman, University of California, Irvine:
nutrition
diet
inflammation
myeloproliferative neoplasm
Additional relevant MeSH terms:
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Neoplasms
Polycythemia Vera
Myeloproliferative Disorders
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders