Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)
University of Miami
Summary
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, is feasible for patients with myeloma precursor disease or newly diagnosed multiple myeloma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 C…
Interventions
- BehavioralHealth Coaching
Participants will receive weekly health coaching sessions via telephone, video call, or in-person. The health coach will contact the participant after randomization to begin the intervention, which will include education on POF and following a Mediterranean diet. Sessions are expected to last 30-45 minutes and may be divided per participant preference. Participant safety and well-being will be addressed at each session, and modifications to the diet or session schedule will be made as necessary and documented. The sessions will be centrally administered by trained nutrition counselors within the Crane Lab under the supervision of a registered dietitian specializing in oncology.
- BehavioralProlonged Overnight Fasting (POF)
Participants will be instructed to not consume any calorie-containing food/drinks after 8pm and to wait 14 hours after the fasting start before resuming eating the next day. Participants will use the My Wellness Research (MWR) platform to record fasting start and stop times and times food intake daily. Additionally, workbook containing educational materials and guidance to support adherence to POF goals will be provided. In the first two weeks, participants will be encouraged to fast for at least 12 hours nightly, gradually increasing to 14 hours. Participants will aim to fast up to 14 hours overnight for six days per week, with the option of taking the seventh day off from fasting.
- BehavioralMediterranean Diet
Participants will be encouraged to adopt key components of the Mediterranean diet, including consuming 4+ vegetable servings (2.5-3 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week.
Location
- University of MiamiMiami, Florida