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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