Table 3 AEs by diet and randomization arm

ITT N = 50	Frequency by diet			Frequency by randomization arm			Preintervention/washout
ITT N = 50	MPF	UPF	P value	MPF/UPF	UPF/MPF	P value	Preintervention/washout
Participants reporting no AE	14	11		2	1		38
Gastrointestinal^a			0.229			0.142
Vomiting/nausea	2	2		0	4
Constipation	3	11		7	7		1
Diarrhea (Loose stools, Frequent stools)	9	7		4	12
Dyspepsia/gastroesophageal reflux^b	29	36		29	36
Gastritis	0	0		0	0		1
Abdominal pain	1	0		1	0
General			0.385			0.465
Fatigue (brain fog, tiredness)	4	16		8	12		1
Sleep related (sleepiness, poor sleep)	1	7		3	5
Headache (including migraine)	2	2		2	2
Dizziness (faint spells, light-headedness, vertigo)	3	4		4	3		1
Forgetfulness	1	0		0	1
Mood change/low mood	4	3		6	1
Acne	2	4		2	4
Musculoskeletal^c	5	7		5	7		1
Dental^d	1	3		3	1		1
Cardio-renal-metabolic			1.000			1.000
Elevated alanine transaminase	1	0		0	1
Mild hepatic steatosis/fatty liver	1	0		1	0
Kidney stone	1	0		1	0
Hematuria	1	0		1	0
Infection			0.739			0.686
COVID-19/viral infection/cold/gastroenteritis	8	15		7	16		6
Cellulitis	0	1		1	0
Scalp inflammation (history of alopecia)	1	0		0	1
Other infection	0	1		0	1
Other			0.236			0.746
Nocturia	0	2		1	1
Hot flushes	1	0		0	1
Premenstrual syndrome/premenstrual dysphoric disorder	1	0		0	1
Body odor change	0	1		1	0
Cough	0	0		0	0		1
Hand burn	0	1		0	1		1
Spider bite	1	0		0	1
Shingles	0	0		0	0		1
Puffy face	0	2		2	0
Panic attack	0	1		0	1
Hospitalization (unknown reason), unrelated SAE	1	0		0	1
Totals			0.088			0.390
Gastrointestinal	44	56		41	59		2
General	23	46		33	36		4
Cardio-renal-metabolic	4	0		3	1		0
Infection	9	17		8	18		6
Other	4	7		4	7		3
Total count	84	126		89	121		15

Statistical comparisons using Fisher’s exact test.
^aGastrointestinal adverse events: two vomiting/nausea, one diarrhea, one dyspepsia/gastresophageal reflux on the MPF diet and one vomiting/nausea, one diarrhea on the UPF diet were not related to the intervention.
^bDyspepsia/gastroesophageal reflux includes heartburn/acid reflux, stomach discomfort, flatulence, bloating, belching, dry heaving and indigestion.
^cMusculoskeletal AEs include muscle cramp, muscle weakness, joint pain, back pain, plantar fasciitis and Achilles tendonitis.
^dDental AEs include dental pain, dental implant infection, gingivitis, caries and cracked tooth. Gastrointestinal adverse events: two vomiting/nausea, one diarrhea, one dyspepsia/gastresophageal reflux on the MPF diet and one vomiting/nausea, one diarrhea on the UPF diet were not related to the intervention. Statistical comparisons using Fisher’s exact test.

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