Study of Prolonged Overnight Fasting Combined With a Mediterranean Diet for Adults With Multiple Myeloma or Its Early Stages

What this Trial Is About

Researchers are evaluating whether a dietary approach combining prolonged overnight fasting with a Mediterranean-style eating pattern is feasible for patients with myeloma precursor disease or newly diagnosed multiple myeloma. The study aims to explore if this combined dietary method can be followed by these patients, providing important insights into diet management during their condition. This is an interventional study sponsored by the University of Miami, focusing on dietary behavior changes and patient adherence. Participants are randomly assigned to one of two groups. The intervention group will follow prolonged overnight fasting where they avoid calorie intake after 8pm and fast for up to 14 hours overnight six days a week, combined with a Mediterranean diet emphasizing vegetables, fruits, whole grains, legumes, nuts, seeds, and seafood. This group will receive health coaching, educational workbooks, nutrition journals, a Fitbit for tracking, and support through a smartphone app or paper logs. The control group will not receive coaching or materials during the study but will be offered one health coaching session after the study ends. The total participation time is about six months for those with precursor disease and about eight months for newly diagnosed multiple myeloma patients, with possible catch-up sessions for missed visits. During the study, participants will engage in weekly health coaching sessions delivered by trained nutrition counselors, who will monitor safety, well-being, and adherence. They will record fasting times and dietary intake daily using an app or paper tracking sheets. Researchers will measure feasibility through participation and retention rates, as well as participant satisfaction over the study period. Secondary outcomes include changes in treatment relative dose intensity and reasons for any changes. The study includes regular monitoring and support to assess how well participants can follow the fasting and dietary guidelines over several months.

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