University of California, Irvine
Irvine, California, 92617, United States
NCT Number: NCT03907436
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Irvine, California, 92617, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive counseling and education on USDA Guidelines for Americans, 2010
Participants will receive counseling and education on a Mediterranean diet.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of California, Irvine
Other
Acronym: NUTRIENT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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