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Table 1 SPIRIT flow diagram of the NAMS study

From: Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study

Visit –1, screening 0, baseline 1, start intervention 2 3 4 5
Month −4 (max) −1 0 3 9 15 18
Informed consent x       
Demographics x       
Inclusion/exclusion criteria x x x x x x x
Case history x       
Medication x x x x x x x
Vital signs x    x x x x
Bioelectrical impedance analysis x     x   x
Anthropometric data x x   x x x x
Hand grip strength x     x   x
Safety laboratory x    x x x x
Research laboratory   x    x   x
Urine sample x    x x x x
Stool sample   x    x   x
Multiple Sclerosis Quality of Life-54 x     x   x
Questionnaire on activities x     x   x
Beck Depression Inventory II x     x   x
Fatigue Severity Scale x     x   x
Physical examination x     x   x
Multiple Sclerosis Functional Composite x     x   x
Symbol Digit Modalities Test x     x   x
Six-minute walk test x     x   x
Expanded Disability Status Scale x     x   x
Relapse query x x x x x x x
AE/SAE query   x x x x x x
MRI   x    x   x
Four-day food record   x    x   x
Nutritional counseling    x * * * *
  1. AE adverse event, MRI magnetic resonance imaging, SAE serious adverse event
  2. *There are 10 group sessions for nutritional counseling within 18 months. The fasting diet group has additional meetings during their 7-day-fasts at baseline and after 6 and 12 months