Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01915433
Eligibility Criteria:
Inclusion Criteria - to complete 2 week RUN IN to determine eligibility for Main Study:
Inclusion Criteria -
1. Secondary or Primary Progressive MS, relapsing progressive MS, relapsing- remitting MS
2. Generally able to walk 25 feet in less than 60 seconds;
3. significant fatigue as documented by a fatigue severity scale score of 4 or more OR a modified fatigue impact scale score of 38 or higher.
4. age between 30 and including 65 at entry into the RUN IN study,
5. non smoker,
6. willingness to be randomized
7. Mild gait disability as shown by an EDSS score of 4.5 or higher
8. Confirmed MS diagnosis using McDonald criteria
9. Eating standard American diet.
Exclusion Criteria for RUN IN to determine eligibility:
1. change in medication in the prior 90 days, taking anti-platelet or anticoagulant therapy therapy, or having a major psychiatric disorder making compliance difficult,
2. SELF REPORTED history of current diagnosis of diabetes, or active liver, kidney or clinically significant heart disease,
3. unable to record daily weight at home,
4. eating a vegetarian diet or chronic diarrhea, have already adopted a Paleo Diet (as defined by a complete elimination of grain, dairy, and legumes)
5. unable to cope with 30% in grocery bill,
6. Alanine aminotransferase value \> 2X normal, or elevated creatinine value, (main study only)
7. incompetence.
8. Too low or too high BMI.
9. Inability to follow study diet, which requires shopping carefully and food preparation, by either the study subject or with the help of an adult companion to do the shopping and food preparation.
10. aversion to coconut milk
Main Study Inclusion Criteria
1\) Successful completion of RUN IN Study - which means, the subject completed the various quest. and survey documents that are part of the RUN-IN study, completed the food diary for each day they participated in the RUN-IN, the subject is eating the standard American Diet as documented by the daily food logs and the 24 hour dietary recalls.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT01915433
Study Brief:
Protocol Section:
NCT01915433