Researchers Develop Trial Protocol on Ketogenic and Fasting Diets for Patients With MS – AJMC.com Managed Markets Network

For patients with multiple sclerosis, ketogenic diets and fasting diets may be potentially safe and inexpensive complementary treatment options. However, additional clinical studies and data are needed to prove this theory.

A recent study protocol published in Trials outlined a trial to include 111 patients with relapsing-remitting MS who exhibit disease activity and undergo stable immunomodulatory therapy or no disease-modifying therapy at all. Due to the lack of clinical data, researchers hoping to use this trial to establish the role of KD and FD in patients with MS.

Each patient in the study would be randomized to 1 of 318-month dietary interventions:

The researchers are looking to measure the number of new T2-weighted MRI lesions after 18 months, as well as safety, changes in relapse rate, and disability progression.

Since pharmacological treatments may have substantial side effects, there is a need for complementary treatment options such as specific dietary approaches. Ketone bodies that are produced during fasting diets and ketogenic diets are an alternative and presumably more efficient energy source for the brain, the authors said.

Studies on mice with experimental autoimmune encephalomyelitis showed beneficial effects of KDs and FDs on disease progression, disability, cognition and inflammatory markers. However, clinical evidence on these diets is scarce.

The authors note that such a study, requiring dietary restrictions, will be challenging to ensure daily adherence throughout the entire intervention period. However, they note this trial could help minimize the gap between promising preclinical data and the lack of clinical data.

Preclinical data suggest that a KD and a FD may modulate immunity, reduce disease severity and promote remyelination in the mouse model of MS. However, clinical evidence is lacking. This study is the first clinical study investigating the effects of a KD and a FD on disease progression of MS, authors said.

Reference

Bahr LS, Bock M, Liebscher D, et al. Ketogenic diet and fasting diet as nutritional approaches in multiple sclerosis (NAMS): protocol of a randomized controlled study [published online January 2, 2020]. Trials. doi:10.1186/s13063-019-3928-9.

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Researchers Develop Trial Protocol on Ketogenic and Fasting Diets for Patients With MS - AJMC.com Managed Markets Network