Prolonged overnight fasting combined with a Mediterranean-style diet for people with multiple myeloma or precursor conditions
Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)
This program will test whether longer overnight fasting paired with a Mediterranean-style eating plan is doable for adults with MGUS, smoldering myeloma, or newly diagnosed multiple myeloma who are starting treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07446777 on ClinicalTrials.gov |
What this trial studies
Participants are enrolled into cohorts of MGUS/SMM or newly diagnosed multiple myeloma starting anti-myeloma therapy and will follow a program combining prolonged overnight fasting with a Mediterranean-style diet supported by health coaching and educational materials. The intervention emphasizes longer nightly fasting windows (POF) together with guided food choices and behavioral support to promote adherence. The primary focus is feasibility, monitoring adherence, safety, and acceptability while collecting health and patient-reported outcomes. The program is offered in English and Spanish at the University of Miami / Sylvester Comprehensive Cancer Center and its network sites.
Who should consider this trial
Good fit: Adults (18+) with confirmed MGUS, smoldering multiple myeloma, or newly diagnosed multiple myeloma starting anti-myeloma therapy at University of Miami/Sylvester sites who can consent, speak English or Spanish, and have ECOG performance status under 2 are ideal candidates.
Not a fit: People who already habitually practice structured fasting most of the time (≥50%), who cannot safely fast for medical reasons, or who do not receive their anti-myeloma care at the participating University of Miami sites are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could improve metabolic health, quality of life, and treatment tolerance and might help influence disease control in some patients.
How similar studies have performed: Small clinical and preclinical studies suggest intermittent fasting and Mediterranean diets can improve metabolic markers and may have anticancer effects, but combining prolonged overnight fasting with a Mediterranean-style diet specifically in multiple myeloma is largely novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Tracy E Crane, PhD, RDN — University of Miami
- Study coordinator: Grey Freylersythe, BS
- Email: g.freylersythe@med.miami.edu
- Phone: (305) 243-9832
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.