Recruiting

Mediterranean Diet

Sponsor:

University of Miami

Code:

NCT07446777

Conditions

Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Smoldering Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Health Coaching

Prolonged Overnight Fasting (POF)

Mediterranean Diet

Supportive Materials

Study Details

Brief 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.

Conditions

Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Smoldering Multiple Myeloma

Study ID

NCT07446777

Start date

Apr 7, 2026

Status verified date

Apr, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Health 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.

Prolonged 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.

Mediterranean 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.

Supportive Materials

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.

Primary outcome measure

  • Feasibility: Percentage of Participants That Agree to Participate [ Time Frame: Baseline ]
  • Retention Rate Among Participants Assigned to the Intervention Arm [ Time Frame: Up to 35 weeks (8 months) ]
  • Satisfaction Rate Among Participants on Both Arms [ Time Frame: Up to 35 weeks (8 months) ]

Central Contacts and Locations

Central contacts

Grey Freylersythe, BS

(305) 243-9832g.freylersythe@med.miami.edu

Michelle Armogan, MHA

(305) 243-7479mda182@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Grey Freylersythe, BS

305-243-9832g.freylersythe@med.miami.edu

Michelle D Armogan, MHA

(305) 243-7479mda182@med.miami.edu

Principal Investigator:

Tracy E Crane, PhD, RDN

More Information

Sponsor

University of Miami

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-05-01.