FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07446777
Status
Recruiting
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Conditions

  • Monoclonal Gammopathy of Undetermined Significance
  • Multiple Myeloma
  • Smoldering Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Health Coaching — BEHAVIORAL
    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.
  • Prolonged Overnight Fasting (POF) — BEHAVIORAL
    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.
  • Mediterranean Diet — BEHAVIORAL
    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.
  • Supportive Materials — BEHAVIORAL
    Participants in the intervention arm will be provided with a workbook with information and support to encourage meeting the POF and Mediterranean diet goals. Additionally, participants will be requested to utilize the My Wellness Research (MWR) platform to track their dietary goals as well as a Fitbit. For participants who choose not to use the app, a paper diet tracking sheet will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to the research team each week. Participants will also receive supportive and informational short message service (SMS) text messages 3 times per week during the study; participants can opt-out of these messages.

Study Details

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.

Key Dates

Start date
Apr 7, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Intervention Group
    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.
  • Experimental: Arm 2: Waitlist Control Group
    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.

Primary Outcome Measure

Feasibility: Percentage of Participants That Agree to Participate [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Grey Freylersythe, BS
[email protected]
305-243-9832
Michelle D Armogan, MHA
[email protected]
(305) 243-7479
Tracy E Crane, PhD, RDN (PRINCIPAL_INVESTIGATOR)
Carl O Landgren, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
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By specialty
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By research site
University of Miami· Miami, FL

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