Multiple Sclerosis, Relapsing-Remitting Clinical Trial
— EDQOfficial title:
Efficacy of Diet on Quality of Life in Multiple Sclerosis
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.
Status | Recruiting |
Enrollment | 156 |
Est. completion date | December 1, 2026 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Univeristy of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Terry L. Wahls |
United States,
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 Me — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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: 10.1080/07315724.2 — View Citation
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 Paleolit — View Citation
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. — View Citation
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 perc — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. | baseline to 3 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. | baseline to 6 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. | baseline to 12 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. | baseline to 18 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) | Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. | baseline to 24 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. | baseline to 3 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. | baseline to 6 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. | baseline to 12 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. | baseline to 18 Months | |
Primary | Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) | Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. | baseline to 24 Months | |
Secondary | Modified Fatigue Impact Scale (MFIS) | Change in MFIS survey questions, scores range from 0-84, lower score is better. | baseline to 3 months | |
Secondary | Modified Fatigue Impact Scale (MFIS) | Change in MFIS survey questions, scores range from 0-84, lower score is better. | baseline to 6 months | |
Secondary | Modified Fatigue Impact Scale (MFIS) | Change in MFIS survey questions, scores range from 0-84, lower score is better. | baseline to 12 months | |
Secondary | Modified Fatigue Impact Scale (MFIS) | Change in MFIS survey questions, scores range from 0-84, lower score is better. | baseline to 18 months | |
Secondary | Modified Fatigue Impact Scale (MFIS) | Change in MFIS survey questions, scores range from 0-84, lower score is better. | baseline to 24 months | |
Secondary | Hospital Anxiety Depression Scale (HADS) | Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence | baseline to 3 months | |
Secondary | Hospital Anxiety Depression Scale (HADS) | Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence | baseline to 6 months | |
Secondary | Hospital Anxiety Depression Scale (HADS) | Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence | baseline to 12 months | |
Secondary | Hospital Anxiety Depression Scale (HADS) | Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence | baseline to 18 months | |
Secondary | Hospital Anxiety Depression Scale (HADS) | Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence | baseline to 24 months | |
Secondary | Fatigue Severity Scale score (FSS) | Change in FSS survey question mean scores, scores range from 1-7, lower is better. | Baseline to 3 months | |
Secondary | Fatigue Severity Scale score (FSS) | Change in FSS survey question mean scores, scores range from 1-7, lower is better. | Baseline to 6 months | |
Secondary | Fatigue Severity Scale score (FSS) | Change in FSS survey question mean scores, scores range from 1-7, lower is better. | Baseline to 12 months | |
Secondary | Fatigue Severity Scale score (FSS) | Change in FSS survey question mean scores, scores range from 1-7, lower is better. | Baseline to 18 months | |
Secondary | Fatigue Severity Scale score (FSS) | Change in FSS survey question mean scores, scores range from 1-7, lower is better. | Baseline to 24 months | |
Secondary | Brain volume as measured by non contrast magnetic resonance imaging (MRI) | Change in MRI grey matter brain volume, more is better | baseline to 24 months | |
Secondary | Brain lesions as measured by non contrast magnetic resonance imaging (MRI) | Change in inflammatory lesions numbers as measured by non contrast brain MRI, fewer is better | baseline to 24 months | |
Secondary | Timed 25 foot walk test | seconds required to walk 25 feet, lower is better | baseline to 3 months | |
Secondary | Timed 25 foot walk test | seconds required to walk 25 feet, lower is better | baseline to 24 months | |
Secondary | 9 Hole peg board test | seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better | baseline to 3 months | |
Secondary | 9 Hole peg board test | seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better | baseline to 24 months | |
Secondary | Low contrast visual acuity | A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better. | baseline to 3 months | |
Secondary | Low contrast visual acuity | A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better. | baseline to 24 months | |
Secondary | 24 hour dietary intake recalls | Change in dietary intake measured by dietary interview conducted via telephone call; more nutrients meeting recommended dietary allowance is better. | baseline to 12 months | |
Secondary | 24 hour dietary intake recalls | Change in dietary intake measured by dietary interview conducted via telephone call; more nutrients meeting recommended dietary allowance is better. | baseline to 24 months | |
Secondary | Critical flicker fusion | The herz at which a flickering light is seen as non-flickering as measured by herz | baseline to 3 months | |
Secondary | Critical flicker fusion | The herz at which a flickering light is seen as non-flickering as measured by herz | baseline to 24 months | |
Secondary | Ocular Coherence tomography | Measure of optic nerve and retina depths using infrared light technology | baseline | |
Secondary | Neurofilament light chain | blood biomarker of neuroaxonal (brain) damage | baseline to 3 months | |
Secondary | Neurofilament light chain | blood biomarker of neuroaxonal (brain) damage | baseline to 24 months |
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