The purpose of this study is to find out whether a dietary approach that includesprolonged overnight fasting, guided by a Mediterranean-style eating pattern, is feasiblefor patients with myeloma precursor disease or newly diagnosed multiple myeloma.
Not Provided
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
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.
University of Miami
Miami, Florida, United States
Investigator: Grey Freylersythe, BS
Contact: 305-243-9832
g.freylersythe@med.miami.edu
Grey Freylersythe, BS
(305) 243-9832
g.freylersythe@med.miami.edu
Michelle Armogan, MHA
(305) 243-7479
mda182@med.miami.edu