Fasting, ketogenic, and anti-inflammatory diets in multiple sclerosis: a randomized controlled trial with 18-month follow-up
Abstract
Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adulthood leading to disability and early retirement. Ketone-based diets improve the disease course in MS animal models and health outcomes in different pilot studies of neurodegenerative diseases. We enrolled 105 individuals with relapsing-remitting MS (RRMS) in an 18-month, randomized, controlled study, and randomized them into (1) standard healthy diet (SD) as recommended by the German Nutrition Society, (2) fasting diet (FD) with 7-day fasts every 6 months with intermittent fasting at 6 of 7 days a week or (3) ketogenic diet (KD) with 20–40 g carbohydrates per day. Primary outcome was the number of new MRI lesions after 18 months in the KD and FD compared to SD and compared to baseline. Secondary outcomes included further MRI outcomes, disease biomarkers as well as metabolic, and clinical MS outcomes. Eighty-one participants completed the study. The primary endpoint number of new T2 lesions after 18 months did not change in any of the groups (SD 0 (0-(-1)), FD 0 (2 − 0), KD 0 (2 − 0)). Secondary endpoints were analyzed exploratorily: Compared to baseline, in the FD group, Neurofilament light chain (NfL) -concentrations were lower at 9 months (-1.94 pg/mL, p = 0.042) and depressive symptoms improved slightly at 18 months (p = 0.079). In the KD group, cognition improved at 18 months (symbol digit modalities test + 3.7, p = 0.020). Cardiometabolic risk markers (body mass…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 105 participants or records.
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