The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase

Sponsor

University of California, Irvine (Other)

Overall Status

Completed

CT.gov ID

NCT03907436

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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)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 :

Oct 1, 2018

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

14-point Mediterranean Diet Adherence Screener (MEDAS) [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

Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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