Dietary Interventions in Human RRMS

limitationsNo results are posted. Planned enrolment and endpoints are not findings.

subjects"eligibilityCriteria": "Eligibility for the run-in phase of the study:\n\nParticipants will be eligible to enroll in the fourteen-day run-in phase of the study if they meet the following inclusion and exclusion criteria:\n\nINCLUSION CRITERIA:\n\n* A definitive diagnosis of RRMS based on the 2017 revised McDonald Criteria.\n* The ability to prepare, or availability of someone to prepare, home-cooked meals.\n* Must own a computer, smartphone, or tablet device that has internet access to complete online surveys and capable of running study related applications.\n* Must be willing to follow study procedures outlined and explained to them.\n* Be between the ages of 18 to 70 at the time of consent.\n* Must be able to walk 25 feet without support.\n* Willingness to be randomized and follow any of the study diets.\n* Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.\n\nEXCLUSION CRITERIA:\n\n* Moderate or severe mental impairment.\n* Use of insulin, Coumadin, weight loss medications such as orlistat that causes fat malabsorption.\n* Worsening of symptoms resulting in the initiation or change of treatment including steroids (solumedrol, prednisone, etc.) or disease-modifying medications in 4 weeks prior to consent.\n* Treatment for cancer by radiation or chemotherapy in 12 months prior to consent, other than skin cancer.\n* Diagnosis of clinically significant heart disease, liver disease, kidney disease, or history of oxalate kidney stones.\n* Diagnosis of type II diabetes that does not have approval from treating physicians to adopt any of the 3 study diets.\n* Clinical diagnosis of moderate to severe psychiatric disease that makes study adherence more difficult (e.g., schizophrenia, bi-polar disease, severe depression and/or anxiety).\n* An active eating disorder such as anorexia, bulimia, binge eating, or orthorexia.\n* Measurement of BMI \\<20.\n* Confirmation of pregnancy or planning to become pregnant in the next 2 years.\n* History of diagnosed fat intolerance/malabsorption such as cholecystectomy or uncontrolled exocrine pancreatic insufficiency.\n* Participation in another research study investigating MS treatments, diet, or exercise.\n* Presence of a contraindication to completing a brain MRI or having claustrophobia which interferes with completion of MRI studies without the use of sedation.",

sample size"count": 162, "type": "ACTUAL"

randomized"allocation": "RANDOMIZED"

controlled"interventionModel": "PARALLEL"

regulatory approval"isFdaRegulatedDrug": false, "isFdaRegulatedDevice": false

research categories"primaryPurpose": "SUPPORTIVE_CARE"

relevant ms typesRandomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study.

intervention"type": "DIETARY_SUPPLEMENT",

comparator"description": "Usual diet with Dietary Guidelines for Americans Diet information"

primary endpoint"measure": "Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)"

follow up"timeFrame": "baseline to 24 Months"

findingsThe overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care.