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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03539094
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of RRMS (2010 Mc Donald criteria).
* EDSS \<6.0 and disease duration ≤ 15 years.
* On an injectable therapy for MS, glatiramer acetate (GA) or beta-interferon (beta-IFN) for at least 3 months prior to the study and with no anticipated changes of the medication for the 12 week study duration.
* Age ≥18 years.
* BMI \> 22 and \< 35 kg/m2 with stable weight in the 3 months prior to screening.
Exclusion Criteria:
* History of any chronic disease process (excluding MS) that could interfere with interpretation of results.
* Diagnosis in the past of an eating disorder (anorexia, bulimia, or binge eating).
* Relapsing at the time of enrollment.
* On corticosteroid treatment (oral or intravenous) in the past month. Nasal corticosteroid treatments are allowed.
* Diagnosis of diabetes or at time of OGTT (fasting glucose \>126 mg/dl or \> 200 mg/dl at 2 hours with a load of 75 g of glucose
* History of food allergies or food intolerance that would interfere with the study.
* History of antibiotic treatment within the past 3 months prior to enrollment
* Use of anticoagulant drugs (like Warfarin or Coumadin) that need to monitor their intake of vegetables containing high levels of vitamin K.
* Currently on a special diet and not willing to stop at least one month prior to enrollment
* Currently taking omega 3/fish oil supplements and not willing to stop administration one month prior to enrollment
* Currently pregnant or plan to become pregnant within 6 months
* Current tobacco or e-cigarette smoker
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03539094
Study Brief:
Protocol Section:
NCT03539094