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phase 2 results: keto diet and MS

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    phase 2 results: keto diet and MS

    Ketogenic Diet Results in Reduced Weight, Fatigue, and Depression in Relapsing Multiple Sclerosis

    October 5, 2022
    Isabella Ciccone, MPH

    In a recent phase 2 study, 6-months of ketogenic diet for people with relapsing multiple sclerosis resulted in a significant reduction in weight, fatigue, and depression, and improved quality of life.

    A recent phase 2 study (NCT03718247) on ketogenic diet in relapsing multiple sclerosis (MS) resulted in participants exhibiting a significant reduction in fat mass as well as a 50% decline in self-reported fatigue and depression scores.1 This study’s findings suggest that ketogenic diets have potential clinical benefits, as dietary changes impact human physiology and immune function, serving as therapeutic strategies.

    After implementing the ketogenic diet, MS Quality of life (QoL) scores significantly improved from 67 (±16) at baseline to 79 (±12; P <.001) at 6 months. Additionally, these patients saw mental health scores improved from 71 (±17) to 82 (±11; P <.001) over the same time period with the MS Qol scale.

    Notably, there were also significant improvements in the Expanded Disability Status Scale scores (2.3 [±0.9] vs 1.9 [±1.1]; P <.001), 6-minute walk time (1631 [±302] vs 1733 [±330];P <.001) and for the Nine-Hole Peg Test scores (21.5 [±3.6] vs 20.3 [±3.7]; P <.001).

    Additionally, the serum leptin with participants was lower, with amounts of 25.5 ng/mL (±15.7) at baseline vs 14.0 ng/mL (±11.7; P <.001) at the end of the treatment period. Additionally, the adiponectin was higher (11.4 µg/mL [±7.8] vs 13.5 µg/mL [±8.4] P =.002) on the ketogenic diets. Based on these results, lead investigator Nicholas Brenton, MD, assistant professor of neurology, Division of Child Neurology, University of Virginia, and colleagues conclude that ketogenic diets are, “safe and tolerable over a 6-month study period and yield improvements in body composition, fatigue, depression, QoL, neurological disability and adipose-related inflammation in persons living with relapsing MS.”

    Brenton and colleagues also noted that their overall results support the rationale for a large-scale study of ketogenic diets as a complementary treatment for MS. However, their data does not support the widespread adoption of ketogenic diets as a therapeutic strategy for MS outside of a clinical trial.

    Notably, the limitation for this study was the lack of a matched control group monitored on a regular or standard diet. Brenton et al wrote, “while the current study lacks controls, the findings herein are essential for next-step phase 3 trial design.” In addition to the lack of control group, another limitation included enrollment which was restricted to patients with clinically-stable relapsing MS. Hence, their findings are not generalizable to a population with active relapsing or progressive MS, which may be focused on in future studies.

    Full story:
    https://www.neurologylive.com/view/k...iple-sclerosis
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