Skip to main content

Table 3 Outcomes: change after 12-week intervention and 12 weeks of sustained intervention relative to observation period

From: Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial

Primary outcome measure:
 1. Perceived fatigue assessed by FSS.
Secondary outcome measures:
 1. Perceived fatigue assessed by MFIS;
 2. Perceived fatigue assessed by FSMCF;
 3. Gait speed assessed by T25FW;
 4. Distance walked assessed by 6MWT;
 5. Speed of task completion in 9HPT;
 6. Number of correct responses assessed by SDMT-O;
 7. Quality of life as measured by MSQOL-54;
 8. Quality of life as measured by SF-36;
 9. MSISv2 score;
 10. Anxiety and depression as measured by HADS;
 11. Physical activity (average daily steps and average minutes spent sedentary, light intensity physical activity, moderate intensity physical activity and vigorous intensity physical activity) and sleep (total sleep time, sleep efficiency) as measured by the accelerometer;
 12. Sleep quality as measured by PSQI;
 13. Stress as measured by PSS-10;
 14. Physical activity as assessed by IPAQ-L;
 15. Cognitive performance as measured by PDQ;
 16. Change in mood as measured by the MHI.
 17. Nutritional adequacy of the diet as measured by food frequency questionnaire (FFQ) and food records;
 18. Changes in blood biomarkers (insulin, glucose, hemoglobin A1c, lipids including HDL, vitamin K, vitamin D, calcium, vitamin B12, folate, homocysteine, complete blood count with differential, Cardio IQ® [fatty acid levels]).
  1. Abbreviations: 6MWT 6-Minute walk test, 9HPT 9-hole Pegboard Test, Cardio IQ® Omega-3 (EPA + DHA) Index, Omega-6/Omega-3 Ratio, EPA/Arachidonic Acid Ratio, Arachidonic Acid, EPA, and DHA, DHA Docosahexaenoic acid, EPA Eicosapentaenoic acid, FFQ Food Frequency Questionnaire, FSMCF Fatigue Scale for Motor and Cognitive Function, FSS Fatigue Severity Scale, HADS Hospital Anxiety and Depression Scale, HDL High Density Lipoprotein, IPAQ-L International Physical Activity Questionnaire–Long, MFIS Modified Fatigue Impact Scale, MHI Mental Health Inventory, MSIS v2 Multiple Sclerosis Impact Scale version 2, MSQ Medical Symptoms Questionnaire, MSQOL54 Multiple Sclerosis Quality of Life 54, PDQ Perceived Deficits Questionnaire, PSQI Pittsburgh Sleep Quality Index, PSS 10 Perceived Stress Scale 10, SDMT-O Symbol Digit Modalities Test-Oral, SF-36 36-item Short Form Health Survey, SPMSQ Short Portable Mental Status Questionnaire, T25FW Timed 25-foot Walk