Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 31, 2023
Date Accepted: Nov 23, 2023
Prolonged nightly fasting for multiple myeloma prevention (PROFAST): design and rationale of a randomized controlled pilot trial
ABSTRACT
Background:
Obesity is an established, modifiable risk factor of multiple myeloma (MM), yet no lifestyle interventions are routinely recommended for overweight and obese patients with MM precursor conditions. Prolonged nightly fasting is a simple, practical dietary regimen, supported by research suggesting that the synchronization of feeding-fasting timing with sleep-wake cycles favorably affects metabolic pathways implicated in the development of MM. We describe the design and rationale of a randomized controlled pilot trial evaluating the efficacy of a regular, prolonged nighttime fasting schedule among overweight and obese individuals at high risk for developing MM or a related lymphoid malignancy.
Objective:
The PROFAST Study is a randomized controlled pilot trial investigating the effects of a 4-month prolonged nightly fasting regimen on body composition and tumor biomarkers among overweight and obese individuals with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), or smoldering Waldenström macroglobulinemia (SWM).
Methods:
Individuals with MGUS, SMM, or SWM aged >18 years and a body mass index of 25 kg/m2 or above are randomized to either a14-hour nighttime fasting intervention (n=20) or a healthy lifestyle education control group (n=20). Participants receiving the fasting intervention are supported through one-on-one telephone counseling by a health coach as well as automated text messaging to support fasting goals. Primary endpoints of body composition (by Dual-Energy X-ray Absorptiometry scan), bone marrow adiposity (by bone marrow histology), and tumor biomarkers (M-protein and light chain concentrations by gel-based and serum free light chain assays) are assessed at baseline and at the end of the 4-month study period.
Results:
Participant recruitment commenced in April 2023 and is expected to be completed by April 2024.
Conclusions:
This study will serve as an important first step in exploring the premise that prolonged nightly fasting is a strategy to control obesity and prevent and intercept disease progression in individuals with MM precursor conditions. Findings from this pilot study may inform clinical and public health strategies for MM prevention. Clinical Trial: ClinicalTrials.gov NCT05565638
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