Randomised controlled trial of intermittent calorie restriction in people with multiple sclerosis.
Document Type
Article
Abstract
BACKGROUND: Calorie restriction (CR) ameliorates preclinical models of multiple sclerosis (MS) via multiple mechanisms. These include decreased leptin, a proinflammatory adipokine, but mechanistic studies in humans are lacking. Tests of daily and intermittent CR (iCR) in people with MS (pwMS) showed improvements in fatigue and well-being measures. This trial studied the effects of 12-week iCR on metabolic, immunological, and clinical outcomes in pwMS.
METHOD: Relapsing-remitting MS participants were randomised to iCR or a control group. Study visits were conducted at baseline, 6 and 12 weeks. The primary outcome was reduction in serum leptin levels at 12 weeks. Feasibility and safety were assessed by diet adherence and adverse events (AEs). Secondary outcomes included changes in anthropometric and body composition measures, metabolic and immunologic profiling, and clinical measures. Mixed effects linear regression models were used to evaluate outcome differences between and within groups over time.
RESULTS: Forty-two pwMS were randomised, 34 completed the study (17/group). Leptin serum levels at 12 weeks were significantly lower in the iCR versus the control group (mean decrease -6.98 µg/dL, 95% CI: -28.02 to 14.06; p=0.03). Adherence to iCR was 99.5% and 97.2% at 6 and 12 weeks, respectively, and no serious AEs were reported. An increase in blood CD45RO
CONCLUSIONS: iCR has the potential to benefit metabolic and immunologic profiles and is safe and feasible in pwMS.
TRIAL REGISTRATION NUMBER: NCT03539094 .
Publication Date
8-20-2024
Publication Title
Journal of neurology, neurosurgery, and psychiatry
ISSN
1468-330X
PubMed ID
39137977
Digital Object Identifier (DOI)
10.1136/jnnp-2024-333465
Recommended Citation
Ghezzi, Laura; Tosti, Valeria; Shi, Lisa; Cantoni, Claudia; Mikesell, Robert; Lancia, Samantha; Zhou, Yanjiao; Obert, Kathleen; Dula, Courtney; Sen, Monokesh K; Ge, Anjie; Tolentino, Miguel; Bollman, Bryan; Don, Anthony S; Matarese, Giuseppe; Colamatteo, Alessandra; La Rocca, Claudia; Lepore, Maria Teresa; Raji, Cyrus A; Rahmani, Farzaneh; Wu, Gregory F; Naismith, Robert T; Fontana, Luigi; Cross, Anne H; Salter, Amber; and Piccio, Laura, "Randomised controlled trial of intermittent calorie restriction in people with multiple sclerosis." (2024). Translational Neuroscience. 2381.
https://scholar.barrowneuro.org/neurobiology/2381