She added that in pilot observations for efficacy, the drop in ketones was accompanied by a reduction in migraine frequency from a mean of 16 days/month to 8 days/month, "and that is within the first month of supplementation."

The participants reported no serious side effects, but one did drop out because of gastrointestinal upset and unpleasant taste of the solution.

Possible Mechanisms

Gross gave a detailed explanation of the possible mechanisms underlying the beneficial effect of a supplement rich in KBs.

"We know that ketone bodies are not only metabolized, they're also signaling molecules. First of all, they're a more efficient fuel than glucose. Per molecule, they produce a lot more ATP [adenosine triphosphate] than a molecule of glucose," she said. "They also induce mitochondrial biogenesis, [and] they're very potent reactive oxygen species inhibitors

Further, they produce less oxidative stress per molecule burned and reduce brain excitability, she added. "They shift the equilibrium between glutamate and GABA [γ-aminobutyric acid] in the direction of GABA, and they also have an influence on glutamate transport itself."

She went on to note that supplying more KBs increases ketone body transporter mechanisms, they are anti-inflammatory, and they reduce blood glucose levels. "So they have a variety of potential migraine-relevant mechanisms in addition to being a more effective fuel" than glucose.

She and her colleagues have started enrolling patients with migraine in a double-blind, randomized, placebo-controlled trial (NCT03132233) to test the bHB supplement in a crossover design over 3 months in a group of 90 participants.

The impetus for this work was the fact that Gross developed migraines in her mid-teens, and she said she wants something that will work for her and for many other patients with migraine. The side effects of currently approved prophylactic drugs are "intolerable for most patients," she said, and avoiding food and lifestyle triggers of migraines severely limits ones activities and life.

Tthere was no commercial funding of the study. Ms Gross has disclosed no relevant financial relationships. Dr Silberstein is a consultant to Alder, Allergan, Autonomic Technologies, Avanir, Curelater Inc, Depomed, Dr. Reddy's Laboratories, Ensured Inc, electroCore Medical LLC, eNeura Therapeutics, INSYS Therapeutics, Lilly USA LLC, Supernus Pharmaceuticals, Teva Pharmaceuticals, Theranica, and Trigemina Inc.

18th Congress of the International Headache Society (IHC) 2017. Abstract PO-01-069. Presented September 8, 2017.

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