Needham · BJPsych open 2023 · single-arm pilot feasibility trial · n=27

Pilot study of a ketogenic diet in bipolar disorder.

Cited 56 times in the scientific literature.

Level 4 - case-series / case-control

Uncontrolled single-arm pilot feasibility study

PubMed 37814952 · doi:10.1192/bjo.2023.568 · record verified 2026-08-28

What was done

Euthymic individuals with bipolar disorder were recruited to a single-arm 6-8 week pilot trial of a modified ketogenic diet to assess recruitment and feasibility. Daily blood ketone and glucose levels were measured, alongside daily ecological momentary assessments of symptoms and recordings of adverse events.

What was found

Of 27 recruited participants, 26 commenced and 20 completed the 6-8 week diet. The dataset achieved 95% completeness for daily ketone, glucose, and symptom measures. Mean daily blood ketone level was 1.3 mmol/L (s.d. = 0.77, median = 1.1), with 91% of readings indicating ketosis. Over 91% of daily blood glucose readings were normal, and 9% indicated mild hypoglycemia. Eleven minor adverse events occurred (fatigue, constipation, drowsiness, hunger), and one serious adverse event occurred (euglycemic ketoacidosis in a participant taking an SGLT2 inhibitor).

Why it matters

This pilot demonstrates that individuals with euthymic bipolar disorder can adhere to a modified ketogenic diet and maintain ketosis, supporting the feasibility of a future randomized trial while highlighting safety considerations with SGLT2 inhibitors.

Limits

The study was a single-arm feasibility trial without a control group. The sample was small (n = 27 recruited, 20 completed), restricted only to euthymic individuals, and evaluated for a short duration (6-8 weeks).

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