Actively Recruiting
Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)
Led by University of Miami · Updated on 2026-05-01
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a dietary approach combining prolonged overnight fasting with a Mediterranean-style eating pattern is feasible for patients with myeloma precursor disease or newly diagnosed multiple myeloma. The study aims to explore if this combined dietary method can be followed by these patients, providing important insights into diet management during their condition. This is an interventional study sponsored by the University of Miami, focusing on dietary behavior changes and patient adherence. Participants are randomly assigned to one of two groups. The intervention group will follow prolonged overnight fasting where they avoid calorie intake after 8pm and fast for up to 14 hours overnight six days a week, combined with a Mediterranean diet emphasizing vegetables, fruits, whole grains, legumes, nuts, seeds, and seafood. This group will receive health coaching, educational workbooks, nutrition journals, a Fitbit for tracking, and support through a smartphone app or paper logs. The control group will not receive coaching or materials during the study but will be offered one health coaching session after the study ends. The total participation time is about six months for those with precursor disease and about eight months for newly diagnosed multiple myeloma patients, with possible catch-up sessions for missed visits. During the study, participants will engage in weekly health coaching sessions delivered by trained nutrition counselors, who will monitor safety, well-being, and adherence. They will record fasting times and dietary intake daily using an app or paper tracking sheets. Researchers will measure feasibility through participation and retention rates, as well as participant satisfaction over the study period. Secondary outcomes include changes in treatment relative dose intensity and reasons for any changes. The study includes regular monitoring and support to assess how well participants can follow the fasting and dietary guidelines over several months.
CONDITIONS
Brief Title
FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Any sex or gender
- Able to provide consent
- Able to speak, read, and understand English or Spanish
- Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard criteria
- Receiving anti-myeloma therapy at specified institutions
- Approval from treating oncologist
- Eastern Cooperative Oncology Group (ECOG) Performance Status grade less than 2 (PI approval needed if grade 2 or higher)
- Not regularly fasting for 12 or more hours nightly for the past 3 months
- Not following a Mediterranean diet meeting 2 or more key components in the past 3 months
- Internet access on a smartphone, tablet, or computer
- Willing to be randomized to diet intervention or control group
You will not qualify if you...
- Younger than 18 years of age
- Unable to provide consent
- Unable to read or understand English or Spanish
- Any contraindication for diet changes as determined by physician
- History of a clinical eating disorder
- History of dementia or major psychiatric disease
- History of stroke, myocardial infarction, or congestive heart failure within the past year
- History of autoimmune disease and currently on treatment at time of screening
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) to determine eligibility
Duration - Approximately 6 months (24 weeks) for precursor disease or 8 months (35 weeks) for multiple myeloma, with an additional 4 weeks for catch-up sessions if needed
Participants receive weekly health coaching sessions focusing on prolonged overnight fasting and adopting a Mediterranean diet, supported by educational materials, dietary tracking tools, and optional Fitbit use. Participants work to fast overnight for up to 14 hours six days per week and follow dietary guidelines for six to eight months depending on disease status.
Weekly coaching sessions via telephone, video call, or in-person
Duration - 4 weeks post-intervention
Participants in the control group receive one health coaching session after the study ends to learn about fasting and the Mediterranean diet. Satisfaction and retention are monitored up to 35 weeks.
1 health coaching session (in-person or virtual)
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
G
Grey Freylersythe, BS
M
Michelle Armogan, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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