NCT03907436

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	USDA Diet	Participants will receive counseling and education on USDA Guidelines for Americans, 2010
OTHER	Mediterranean Diet	Participants will receive counseling and education on a Mediterranean diet.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2019-04-09
• Last updated: 2020-03-24

Locations

1 site across 1 country: United States