Efficacy of Diet on Quality of Life in Multiple Sclerosis (EDQ)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2026
  • participants needed
    156
  • sponsor
    Terry L. Wahls
Updated on 4 October 2022
Accepts healthy volunteers

Summary

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.

Description

In the United States, MS affects nearly 1 million people with a 2.8:1 female to male ratio and the highest incidence rates among whites and African Americans. The economic cost of managing MS is substantial. In the U.S., the total medical costs for patients with MS increased from $116 million in 2002 to $198 million in 2013. MS is a chronic, neuroinflammatory, and neurodegenerative disease-causing symptoms of pain, fatigue, and changes in vision, cognition, and movement that greatly reduce quality of life (QoL) and the ability to maintain employment.

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.

The proposed study will consist of study participants attending 3 in-person site visits, months 0, 3, and 24, and online surveys every 3 months (months 0-24).

This study will use a randomized single-blind controlled design to test the short-term (6 months) and long-term (an additional 18 months) impact of the intervention diets on symptoms of MS including QoL and related outcomes stated above. We will use a fourteen-day run-in period to identify participants who are most likely to be successful in completing study procedures; this process has been effective in our previous studies. Participants who successfully complete all baseline self-reported outcomes and follow all study procedures during the seven-day run-in period will be scheduled for an on-site baseline visit for randomization to one of three diets (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination and Dietary Guidelines for America).

On-site study visits will include blood draws, motor, cognitive, vision function assessments, and MRI. Motor assessments will include a 6-minute walk test, 25-foot walk test, 9-hole pegboard to test hand function, symbol digit exercise to test thinking functions, and critical flicker fusion test, ocular coherence tomography and low contrast vision sensitivity to test vision. The study participant will be escorted to the MRI unit to complete a non-contrast MRI of the brain. At the baseline visit, participants will be randomized. Participants assigned to the intervention diets will be given intervention specific educational materials including shopping lists, example menus and recipes, and the study supplements. Study participants randomized to the dietary guidelines for Americans diet will receive emails and/or text messages (approximately 3-6 weeks) to receive resources with websites for the Dietary Guidelines of America, and recent multiple sclerosis-related research that does not involve diet.

Study team will provide fish oil, essential fatty acids, and phosphatidylcholine to the two intervention groups only. The participant will be scheduled for a Zoom video conference meeting with the assigned registered dietitian to review the assigned study diet.

In addition, subjects will collect saliva specimens for microbiome analysis at each of the 2 site study visits (month 0 and 24).

24-hour dietary recalls will be collected by a study registered dietitian (RD) (who did not provide training on the respective participants assigned study diet) on three non-consecutive days at baseline, and one per month, at months 10-12, and 22-24. Participants will be given a 3-month window to complete dietary recalls in the event of scheduling conflicts. Participants will be instructed to record key study diet components each day using a study specific questionnaire in the study related (MyCap) application on their smart device.

The online questionnaires sent to participants every 2 months will also be used to track supplement intake, medication use, and details about health & life events, MS symptoms, fatigue, quality of life, doctor's appointment, and side effects they may be experiencing.

Details
Condition Multiple Sclerosis, Relapsing-Remitting
Treatment BodyBio Balance Oil, Kirunal Fish Oil, BodyBio PC, Modified Paleolithic Elimination diet, Time Restricted Olive Oil Based (TROO) Ketogenic Diet, Usual diet with Dietary Guidelines for Americans Diet information
Clinical Study IdentifierNCT05007483
SponsorTerry L. Wahls
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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