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Efficacy of Diet on Quality of Life in Multiple Sclerosis

Active Not RecruitingNA

Sponsor: Terry L. Wahls

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: BodyBio Balance Oil, Kirunal Fish Oil, BodyBio PC, Modified Paleolithic Elimination diet, Time Restricted Olive Oil Based (TROO) Ketogenic Diet

Countries: United States

The 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. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Eligibility for the run-in phase of the study:

Participants will be eligible to enroll in the fourteen-day run-in phase of the study if they meet the following inclusion and exclusion criteria:

INCLUSION CRITERIA:

* A definitive diagnosis of RRMS based on the 2017 revised McDonald Criteria.
* The ability to prepare, or availability of someone to prepare, home-cooked meals.
* Must own a computer, smartphone, or tablet device that has internet access to complete online surveys and capable of running study related applications.
* Must be willing to follow study procedures outlined and explained to them.
* Be between the ages of 18 to 70 at the time of consent.
* Must be able to walk 25 feet without support.
* Willingness to be randomized and follow any of the study diets.
* Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.

EXCLUSION CRITERIA:

* Moderate or severe mental impairment.
* Use of insulin, Coumadin, weight loss medications such as orlistat that causes fat malabsorption.
* 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.
* Treatment for cancer by radiation or chemotherapy in 12 months prior to consent, other than skin cancer.
* Diagnosis of clinically significant heart disease, liver disease, kidney disease, or history of oxalate kidney stones.
* Diagnosis of type II diabetes that does not have approval from treating physicians to adopt any of the 3 study diets.
* 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).
* An active eating disorder such as anorexia, bulimia, binge eating, or orthorexia.
* Measurement of BMI \<20.
* Confirmation of pregnancy or planning to become pregnant in the next 2 years.
* History of diagnosed fat intolerance/malabsorption such as cholecystectomy or uncontrolled exocrine pancreatic insufficiency.
* Participation in another research study investigating MS treatments, diet, or exercise.
* Presence of a contraindication to completing a brain MRI or having claustrophobia which interferes with completion of MRI studies without the use of sedation.

Locations (1)

Iowa City, Iowa, United States