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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02647502
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-50
* Capable of storing food safely, willing to follow diet/eat provided food, and able to receive shipments at home or work
* Meets 2010 criteria for McDonald MS;
* Relapse or new lesion in previous 2 years
* Expanded disability status score (EDSS) \< 6
* Disease duration ≤15 years
* Untreated or on stable on first-line MS therapy \[injectable\] for at least 6 months, with no anticipated changes in the next 10 weeks
* Unchanged vitamin D dose or thyroid replacement dose (for those on it) with no anticipated changes or in supplement use for the next 10 weeks.
* Non-regular smoker (average no more than 1 cigarette/day) for at least 2 months
* Stable weight, by self report, for past 3 months (± 8 lbs)
* Body mass index (BMI) \> 23 kg/m2
Exclusion Criteria:
* Pregnant or nursing, or unwilling to prevent pregnancy (if of childbearing to potential)
* History of gastrointestinal disease causing malabsorption
* History of diabetes requiring medication
* History of stage IV/V chronic kidney disease or vascular disease
* History of major surgery in past 3 months
* Current use of warfarin
* History of eating disorder
* Currently on a special diet for MS/other diet (provided diet will be pork free)
* Chemotherapy within the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02647502
Study Brief:
Protocol Section:
NCT02647502