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

NCT ID: NCT03907436

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-10-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

USDA Diet

Intervention Type: OTHER

Participants will receive counseling and education on USDA Guidelines for Americans, 2010

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.

Group Type: EXPERIMENTAL

Mediterranean Diet

Intervention Type: OTHER

Participants will receive counseling and education on a Mediterranean diet.

Interventions

USDA Diet

Participants will receive counseling and education on USDA Guidelines for Americans, 2010

Intervention Type: OTHER

Mediterranean Diet

Participants will receive counseling and education on a Mediterranean diet.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Angela G. Fleischman

Assistant Professor, Division of Hematology/Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela G Fleischman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.wearempn.org/interestedinenrolling

website with more information on the diet and enrollment information

Other Identifiers

18-30

Identifier Type: OTHER

Identifier Source: secondary_id

2018-4521

Identifier Type: -

Identifier Source: org_study_id