Fasting and mediterranean diet tested in blood cancer patients
NCT ID NCT07446777
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a diet that includes longer overnight fasting and follows a Mediterranean eating pattern is practical for people with multiple myeloma or its early forms (MGUS or smoldering myeloma). About 120 adults will try this approach to see if they can stick with it and find it helpful. The goal is to see if this diet is feasible and acceptable, not to cure the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 years of age or older. 2. Any sex/gender. 3. Able to provide consent. 4. Able to speak, read, and understand English or Spanish. 5. Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard criteria: 1. Cohort 1 - Participants must have a confirmed diagnosis of MGUS and SMM. 2. Cohort 2 - Participants must have a confirmed new diagnosis of MM and be initiating anti-myeloma therapy. 6. Delivery of anti-myeloma therapies at one of the following institutions: 1. Sylvester Comprehensive Cancer Center (SCCC) (including satellite/network sites). 2. University of Miami Health System. 7. Approval from treating oncologist, confirmed via email or in writing. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status grade of \<2 a. PI approval needed if ECOG ≥ 2. 9. Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months. 10. Not consuming a Mediterranean diet by not meeting 2 or more out of the following 3 Mediterranean eating pattern goals in the prior 3 months: ≥3 servings of vegetables per day, ≥ 3 servings of beans and legumes per week, or ≥ 1 serving of nuts per day. Mediterranean diet will be screened with select components of a Mediterranean Diet Adherence Screener (MEDAS). 11. Internet access on a smart phone, tablet, or computer. 12. Willing to be randomized to a prolonged overnight fasting and guided Mediterranean dietary intervention or waitlist-control group. Exclusion Criteria: 1. Individuals younger than 18 years of age. 2. Unable to provide consent. 3. Unable to read or understand English or Spanish. 4. Any contraindication for diet changes as determined by physician. 5. History of a clinical eating disorder. 6. History of dementia or major psychiatric disease. 7. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure. 8. History of autoimmune disease and on treatment at time of screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?