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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, screening0, baseline1, start intervention2345
Month−4 (max)−10391518
Informed consentx      
Demographicsx      
Inclusion/exclusion criteriaxxxxxxx
Case historyx      
Medicationxxxxxxx
Vital signsx  xxxx
Bioelectrical impedance analysisx   x x
Anthropometric dataxx xxxx
Hand grip strengthx   x x
Safety laboratoryx  xxxx
Research laboratory x  x x
Urine samplex  xxxx
Stool sample x  x x
Multiple Sclerosis Quality of Life-54x   x x
Questionnaire on activitiesx   x x
Beck Depression Inventory IIx   x x
Fatigue Severity Scalex   x x
Physical examinationx   x x
Multiple Sclerosis Functional Compositex   x x
Symbol Digit Modalities Testx   x x
Six-minute walk testx   x x
Expanded Disability Status Scalex   x x
Relapse queryxxxxxxx
AE/SAE query xxxxxx
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