Randomized crossover trial of a modified ketogenic diet in Alzheimer’s disease

Phillips, Matthew C. L.; Deprez, Laura M.; Mortimer, Grace M. N.; Murtagh, Deborah K. J.; McCoy, Stacey; Mylchreest, Ruth; Gilbertson, Linda J.; Clark, Karen M.; Simpson, Patricia V.; McManus, Eileen J.; Oh, Jee-Eun; Yadavaraj, Satish; King, Vanessa M.; Pillai, Avinesh; Romero-Ferrando, Beatriz; Brinkhuis, Martijn; Copeland, Bronwyn M.; Samad, Shah; Liao, Shenyang; Schepel, Jan A. C.

doi:10.1186/s13195-021-00783-x

Alzheimer's Research & Therapy

Table 4 Cardiovascular risk factor data for all randomized patients, showing mean baseline values and changes at week 12 (data shown by treatment period, by treatment sequence, and for all patients)

From: Randomized crossover trial of a modified ketogenic diet in Alzheimer’s disease

	First treatment period		Second treatment period		All patients		Treatment effect
	Ketogenic-usual diet (n = 13)	Usual-ketogenic diet (n = 13)	Ketogenic-usual diet (n = 13)	Usual-ketogenic diet (n = 13)	Ketogenic diet (n = 26)	Usual diet (n = 26)	Treatment effect
Weight (kg)
Baseline	86.1 ± 18.4	75.5 ± 11.5	85.2 ± 17.5	75.0 ± 10.8	80.5 ± 15.8	80.4 ± 15.4	−2.62 ± 3.29 (P = 0.0017)
Change at week 12	−2.54 ± 3.66	−0.50 ± 1.82	+ 1.29 ± 1.39	− 1.90 ± 1.22	−2.22 ± 2.69	+ 0.40 ± 1.83	−2.62 ± 3.29 (P = 0.0017)
Body mass index
Baseline	27.8 ± 5.9	26.6 ± 2.7	27.6 ± 5.5	26.5 ± 2.7	27.1 ± 4.5	27.1 ± 4.3	− 0.95 ± 1.35 (P < 0.001)
Change at week 12	− 0.95 ± 1.40	− 0.17 ± 0.63	+ 0.44 ± 0.50	− 0.68 ± 0.42	− 0.81 ± 1.02	+ 0.14 ± 0.64	− 0.95 ± 1.35 (P < 0.001)
HbA1C (mmol/mol)
Baseline	34.4 ± 3.2	38.5 ± 6.6	35.7 ± 3.0	40.5 ± 9.3	37.5 ± 7.5	37.1 ± 5.2	− 2.73 ± 5.17 (P = 0.0047)
Change at week 12	− 0.88 ± 1.27	+ 0.23 ± 1.59	0.00 ± 2.00	−4.35 ± 7.00	−2.61 ± 5.24	+ 0.12 ± 1.77	− 2.73 ± 5.17 (P = 0.0047)
Triglycerides (mmol/L)
Baseline	2.45 ± 1.19	2.00 ± 0.89	2.20 ± 0.82	1.84 ± 0.55	2.15 ± 0.96	2.10 ± 0.84	− 0.32 ± 1.34 (P = 0.20)
Change at week 12	− 0.43 ± 1.18	− 0.06 ± 0.92	+ 0.20 ± 0.83	− 0.07 ± 0.66	− 0.25 ± 0.96	+ 0.07 ± 0.87	− 0.32 ± 1.34 (P = 0.20)
HDL (mmol/L)
Baseline	1.30 ± 0.30	1.49 ± 0.40	1.40 ± 0.34	1.55 ± 0.40	1.43 ± 0.37	1.45 ± 0.37	+ 0.36 ± 0.32 (P < 0.001)
Change at week 12	+ 0.27 ± 0.26	− 0.02 ± 0.23	− 0.04 ± 0.13	+ 0.40 ± 0.28	+ 0.33 ± 0.28	−0.03 ± 0.18	+ 0.36 ± 0.32 (P < 0.001)
LDL (mmol/L)
Baseline	2.68 ± 1.19	2.64 ± 0.88	2.83 ± 1.21	2.65 ± 0.85	2.67 ± 1.01	2.73 ± 1.04	+ 0.38 ± 1.06 (P = 0.039)
Change at week 12	+ 0.16 ± 0.69	−0.21 ± 0.55	+ 0.30 ± 0.56	+ 0.69 ± 0.87	+ 0.42 ± 0.81	+ 0.04 ± 0.61	+ 0.38 ± 1.06 (P = 0.039)
Total cholesterol (mmol/L)
Baseline	5.08 ± 0.96	5.05 ± 0.95	5.22 ± 1.22	5.02 ± 0.92	5.05 ± 0.92	5.13 ± 1.07	+ 0.62 ± 1.23 (P = 0.012)
Change at week 12	+ 0.29 ± 0.63	−0.26 ± 0.65	+ 0.35 ± 0.50	+ 1.04 ± 0.94	+ 0.66 ± 0.87	+ 0.04 ± 0.65	+ 0.62 ± 1.23 (P = 0.012)

Values are presented as mean ± standard deviation
Regarding withdrawals, regression imputation was used to calculate the value at week 12
Treatment effects and P values refer to the difference between the ketogenic and usual diet mean within-individual change at week 12 (for all patients)
HbA1C glycosylated haemoglobin, HDL high-density lipoprotein, LDL low-density lipoprotein

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