Mediterranean Diet + Fasting for Multiple Myeloma
(FAST-M Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a combination of prolonged overnight fasting and a Mediterranean diet is feasible for individuals with certain myeloma conditions. The focus is on those with early-stage myeloma or newly diagnosed multiple myeloma. Participants will either begin this dietary routine immediately or join a waitlist for later participation. Individuals diagnosed with specific myeloma conditions who have not regularly followed a Mediterranean diet or fasted overnight recently may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore new lifestyle interventions that could benefit health.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.
What prior data suggests that this dietary approach is safe for patients with multiple myeloma?
Research has shown that fasting overnight for extended periods and following a Mediterranean diet are generally safe for most people. A small initial study found that patients with early-stage multiple myeloma could follow this approach without major problems. Another study involving overweight individuals found that fasting overnight did not cause serious side effects.
While fasting and eating a Mediterranean diet can alter the body and improve health, these changes are typically manageable. Reports of negative effects are rare, suggesting this diet is safe for most people. However, as with any treatment, individual experiences may vary, so monitoring the body's reactions is important.12345Why are researchers excited about this trial?
Researchers are excited about using a Mediterranean diet combined with prolonged overnight fasting for multiple myeloma because it offers a fresh, non-pharmaceutical approach to managing this condition. Unlike standard treatments like chemotherapy and stem cell transplants, this method focuses on lifestyle changes that may help improve disease outcomes and overall well-being without the side effects of traditional drugs. The Mediterranean diet is rich in fruits, vegetables, whole grains, and healthy fats, which are linked to reduced inflammation and better immune function, while overnight fasting may enhance the body's ability to repair and regenerate cells. This combination could potentially complement existing treatments, offering a holistic strategy to managing multiple myeloma.
What evidence suggests that this dietary intervention is effective for multiple myeloma?
Studies have shown that a high-fiber, plant-based diet can improve health in individuals with conditions that may lead to multiple myeloma. Research also suggests that this diet might slow the disease's progression. In this trial, participants in the intervention group will follow a Mediterranean diet combined with prolonged overnight fasting. This approach was tested in overweight individuals and found to improve body health and reduce tumor markers. These early findings suggest that this dietary strategy might help manage or delay the progression of multiple myeloma.23567
Who Is on the Research Team?
Tracy E Crane, PhD, RDN
Principal Investigator
University of Miami
Carl O Landgren, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for adults (18+) with a new diagnosis of multiple myeloma or its precursor diseases (MGUS, SMM), who are starting treatment at the University of Miami/Sylvester Cancer Center. Participants must not already follow a Mediterranean diet or structured fasting, need internet access, and be able to consent. Certain health conditions like recent heart issues or eating disorders exclude participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive the FAST-M intervention, which includes prolonged overnight fasting and a Mediterranean diet, supported by dietary workbooks, nutrition journals, and a Fitbit.
Follow-up
Participants are monitored for satisfaction and changes in relative dose intensity post-intervention.
What Are the Treatments Tested in This Trial?
Interventions
- Prolonged Overnight Fasting and Mediterranean Dietary Intervention
Trial Overview
The study tests if patients can stick to a prolonged overnight fasting routine combined with a Mediterranean-style diet, supported by coaching and materials. Participants are randomly assigned either to this dietary program or to a waitlist control group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants in this group will not receive any health coaching or study materials until the end of the study four weeks post-intervention, when they will receive one health coaching session, which will describe potential benefits of prolonged overnight fighting (POF) as well as adopting key components of the Mediterranean diet. Total participation duration is about six (6) months.
Participants in this group will receive the FAST-M intervention, which consists of prolonged overnight fasting (POF) and a Mediterranean diet. The intervention will be supported by dietary workbooks, nutrition journals, and a Fitbit to aid in tracking and adherence. Total participation duration is about six (6) months (24 weeks) for participants with myeloma precursor disease; and about eight (8) months (35 weeks for participants with newly diagnosed multiple myeloma (NDMM). An additional +/- four (4) weeks for catch-up sessions may be added for missed sessions, if necessary.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
Design and Rationale of Prolonged Nightly Fasting for ... - PMC
We aim to investigate the effects of 4-month prolonged nightly fasting on body composition and tumor biomarkers among individuals with overweight or obesity.
(PDF) Prolonged nightly fasting for multiple myeloma ...
A recent pilot clinical trial indicated that a plant-based diet is feasible in overweight patients diagnosed with multiple myeloma precursor diseases (MGUS or ...
Prolonged Overnight Fasting and Mediterranean Dietary ...
The purpose of this study is to find out whether a dietary approach that includes prolonged overnight fasting, guided by a Mediterranean-style eating pattern, ...
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aacrjournals.org
aacrjournals.org/cancerdiscovery/article/16/4/697/775559/A-High-Fiber-Plant-Based-Diet-in-Myeloma-PrecursorA High-Fiber, Plant-Based Diet in Myeloma Precursor Disorders
A high-fiber, plant-based diet improved metabolic, microbiome, and immune biomarkers in patients with MGUS/SMM and delayed myeloma ...
PROlonged Nightly FASTing for Obesity Reduction and ...
This is a 4-month randomized trial of a prolonged nightly fasting intervention (PROFAST) in 40 overweight and obese individuals with monoclonal gammopathy ...
Prolonged Overnight Fasting and Mediterranean Dietary ...
The purpose of this study is to find out whether a dietary approach that includes prolonged overnight fasting, guided by a Mediterranean-style ...
FAST-M: Prolonged Overnight Fasting and Mediterranean ...
The purpose of this study is to find out whether a dietary approach that includes prolonged overnight fasting, guided by a Mediterranean-style ...
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