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

NCT03907436 | Completed

• 2 other identifiers: 2018-452118-30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

nutrition; diet; inflammation; myeloproliferative neoplasm

Outcome Measures

Primary Outcomes (1)

• 14-point Mediterranean Diet Adherence Screener (MEDAS)

  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.

  15 weeks

Secondary Outcomes (2)

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

  15 weeks

• Inflammatory cytokines

  15 weeks

Study Arms (2)

USDA diet arm

SHAM COMPARATOR

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

Mediterranean diet arm

EXPERIMENTAL

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

Interventions

USDA Diet OTHER

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

USDA diet arm

Mediterranean Diet OTHER

Participants will receive counseling and education on a Mediterranean diet.

Mediterranean diet arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Children

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92617, United States

Location

Related Publications (1)

• Avelar-Barragan J, Mendez Luque LF, Nguyen J, Nguyen H, Odegaard AO, Fleischman AG, Whiteson KL. Characterizing the microbiome of patients with myeloproliferative neoplasms during a Mediterranean diet intervention. mBio. 2023 Dec 19;14(6):e0230823. doi: 10.1128/mbio.02308-23. Epub 2023 Oct 25.

  PMID: 37877698 DERIVED

Related Links

• website with more information on the diet and enrollment information

MeSH Terms

Conditions

Myeloproliferative Disorders; Primary Myelofibrosis; Polycythemia Vera; Thrombocythemia, Essential; Inflammation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Angela G Fleischman, MD PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Hematology/Oncology

Model Details: Participants will be randomized to one of two healthy diets (USDA or Mediterranean diet)

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 9, 2019
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)