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

University of California Irvine (UCI)

Status: Completed

Conditions: Myelofibrosis; Polycythemia Vera; Myeloproliferative Syndrome; Essential Thrombocythemia; Myeloproliferative Disorder

Treatments: Other: Mediterranean Diet; Other: USDA Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03907436

18-30 (Other Identifier)

2018-4521

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• Children

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

USDA diet arm

Sham Comparator group

Description:

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.

Treatment:

Other: USDA Diet

Mediterranean diet arm

Experimental group

Description:

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.

Treatment:

Other: Mediterranean Diet