EDQ
What it found
No result yet.
What was tested
Treatment tested
- Linoleic acid
- Doconexent
- Phosphatidylcholine
- Modified Paleolithic Elimination diet
- Time Restricted Olive Oil Based (TROO) Ketogenic Diet
Compared with
- Usual diet with Dietary Guidelines for Americans Diet information
What it measured
Main measures
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
baseline to 3 Months
Quality of life (reported by participants)Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
baseline to 6 Months
Quality of life (reported by participants)Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
baseline to 12 Months
Quality of life (reported by participants)Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
baseline to 18 Months
Quality of life (reported by participants)Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
baseline to 24 Months
Quality of life (reported by participants)Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
baseline to 3 Months
Quality of life (reported by participants)Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
baseline to 6 Months
Quality of life (reported by participants)
Other measures (35)
Modified Fatigue Impact Scale (MFIS)
baseline to 3 months
FatigueModified Fatigue Impact Scale (MFIS)
baseline to 6 months
FatigueModified Fatigue Impact Scale (MFIS)
baseline to 12 months
FatigueModified Fatigue Impact Scale (MFIS)
baseline to 18 months
FatigueModified Fatigue Impact Scale (MFIS)
baseline to 24 months
FatigueHospital Anxiety Depression Scale (HADS)
baseline to 3 months
Mood and sleepHospital Anxiety Depression Scale (HADS)
baseline to 6 months
Mood and sleepHospital Anxiety Depression Scale (HADS)
baseline to 12 months
Mood and sleepHospital Anxiety Depression Scale (HADS)
baseline to 18 months
Mood and sleepHospital Anxiety Depression Scale (HADS)
baseline to 24 months
Mood and sleep
Who could take part
Relapsing MS · 18 to 70
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Efficacy of Diet on Quality of life in Multiple Sclerosis (EDQ-MS): a study protocol for a randomized controlled clinical trial.Trials · 2025
Results
Wahls TL, Chenard CA, Snetselaar LG. Review of Two Popular Eating Plans within the Multiple Sclerosis Community: Low Saturated Fat and Modified Paleolithic. Nutrients. 2019 Feb 7;11(2):352. doi: 10.3390/nu11020352.Results
Wahls T, Scott MO, Alshare Z, Rubenstein L, Darling W, Carr L, Smith K, Chenard CA, LaRocca N, Snetselaar L. Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial. Trials. 2018 Jun 4;19(1):Results
Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 1;11(3):537. doi: 10.3390/nu11030537.Results
Titcomb TJ, Bisht B, Moore DD 3rd, Chhonker YS, Murry DJ, Snetselaar LG, Wahls TL. Eating Pattern and Nutritional Risks among People with Multiple Sclerosis Following a Modified Paleolithic Diet. Nutrients. 2020 Jun 20;12(6):1844. doi: 10.3390/nu12061844.Results
Lee JE, Bisht B, Hall MJ, Rubenstein LM, Louison R, Klein DT, Wahls TL. A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis. J Am Coll Nutr. 2017 Mar-Apr;36(3):150-168. doi: 10.1080/07315724.2016.1255160. Epub 2017 Apr 10.Results
Lee JE, Titcomb TJ, Bisht B, Rubenstein LM, Louison R, Wahls TL. A Modified MCT-Based Ketogenic Diet Increases Plasma beta-Hydroxybutyrate but Has Less Effect on Fatigue and Quality of Life in People with Multiple Sclerosis Compared to a Modified Paleolithic Diet: A Waitlist-Controlled, Randomized Pilot Study. J Am Coll Nutr. 2021 Jan;40(1):13-25. doi: 10.1080/07315724.2020.1734988. Epub 2020 MarResults
Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between the Low Saturated Fat Swank Diet for Multiple Sclerosis and Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 13;11(3):616. doi: 10.3390/nu11030616.Results
Irish AK, Erickson CM, Wahls TL, Snetselaar LG, Darling WG. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2017 Jan 4;7:1-18. doi: 10.2147/DNND.S116949. eCollection 2017.Results
Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.
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History
Started
Feb 2022
Main results due
Oct 2026
Finished
Dec 2026
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