An interventional study of Therapeutic diet and lifestyle in Clinically Isolated Syndrome and Relapsing Remitting Multiple Sclerosis, sponsored by Terry L. Wahls. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Terry L. Wahls · Not applicable, Interventional, and Treatment
A key question in efforts to reduce symptoms and improve quality of life for multiple sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple sclerosis related symptoms, improving function and quality of life. This study will prospectively assess the changes in quality of life and clinical outcomes in two cohorts of patients who are recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) to begin answering that question.
The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. Due to the COVID 19 Pandemic, the study was redesigned from an in-person study to a virtual visit only study prior to enrolling study subjects.
The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. The current standard of care typically includes disease-modifying drug treatment at the initial diagnosis of RRMS or CIS. Many patients are interested in adopting a therapeutic lifestyle as their initial approach to either RRMS or CIS. Some patients decline drug therapy due to high costs and or concerns about potential medication adverse events. There are no known scientific studies that have prospectively assessed outcomes for newly-diagnosed patients who decline disease-modifying drug treatment and instead utilized only a therapeutic diet and lifestyle to manage their MS-related symptoms. This study will prospectively investigate the effect of a therapeutic diet and lifestyle on quality of life, motor, cognitive and visual function, and brain structure in patients who have been trained and supported by the study team to utilize therapeutic diet and lifestyle to optimize neuronal health and those who are receiving usual care.
Our initial pilot study in the setting of progressive MS included diet and targeted supplements, stress reduction, exercise, and electrical stimulation of muscles and demonstrated significant reduction in fatigue, improvement in quality of life and improved mood and cognition. Subsequent pilot studies which utilized a diet-only intervention in the setting of RRMS demonstrated improved quality of life and improved walking and hand function.
Intervention arm:
This study will again utilize a multimodal approach, a low-lectin modified Paleolithic elimination diet, stress reduction (breathing meditation exercise) and an exercise (daily walking and three times a week body weight strengthening) program in the absence of drug disease modifying treatment and targeted supplements in the intervention arm. The control arm will receive usual care.
Supplements (intervention arm only) Participants will be asked to continue taking any dietary supplements they report at beginning of study with the exception of supplements that are similar to those they will be taking as part of the study which they will be asked to discontinue and replace with study-approved brands (2 grams of fish oil, 1000 mcg methylB12 , 400 mcg methyl folate, pyridoxine 1.5 mg and N acetylcysteine 500 mg per day, and 2000 IU vitamin D3 .
The study will use videos from a three day seminar that teaches the public how to utilize a therapeutic diet and lifestyle to improve cellular physiology which may favorably impact disease progression to educate study participants. A registered dietitian with training in motivational interviewing and health coaching will call participants to provide coaching and support to participants as they adopt the study diet, breathing meditation and exercise program and begin the study supplements. The study coordinator and or registered dietitian will moderate monthly support group video conference meetings for participants in the intervention arm. The control arm will receive a monthly text/ email providing a summary to a recently published clinical trial related to multiple sclerosis / clinically isolated syndrome patients that is not related to diet quality or use of a therapeutic diet or lifestyle.
AIMS Aim 1: To assess the non-inferiority in the change in perceived fatigue, quality of life, fatigue, mood and cognition compared to usual care over 12 months in newly-diagnosed, disease modifying drug treatment naïve RRMS or CIS patients within and between two groups. Group one will receive standard of care. Group two will receive telehealth support for improving health behaviors in the setting of newly diagnosed RRMS or CIS in which disease modifying treatment had been recommended and declined by the study participant. The pandemic had been declared prior to the first recruitment. The study was converted to virtual study with virtaul support and limited to patient reported outcomes
602 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.
This study's enrollment of 44 is below the median of 72 across 429 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Terry L. Wahls is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1) Moderate or severe mental impairment as measured by the Short Portable Mental Health Questionnaire. 2) Taking insulin or Coumadin® medication. 3) History of oxalate kidney stones, schizophrenia, or active diagnosis of eating disorder. 4) Greater than 12 months since initial diagnosis of RRMS or CIS and first study visit.
Participants will receive usual care from their treating neurologist
Participants will be trained via videos from a three day in-person seminar that teaches the public about the use of a therapeutic diet and lifestyle to reduce multiple sclerosis related fatigue and improve quality of life.
Behavioral: Therapeutic diet and lifestyle
Educational videos, 1 individual support call from RD follwed by monthly support group meetings conducted via an internet based audio/ video conference platform. Patients will be trained on a low lectin modified paleolithic elimination diet; breathing meditation practice, and walking sessions to increase daily moderate to vigorous physiscal activity
MS 54 Quality of Life scale physical health score
Composite scores for physical health subscales
Time frame: change from baseline to 12 months
MS 54 Quality of Life scale mental health score
Composite scores for mental health subscales
Time frame: change from baseline to 12 months
Fatigue Severity Score
Questionnaire asking about fatigue
Time frame: Baseline to 12
Modified Fatigue Impact Scale
Questionnaire asking about fatigue
Time frame: Baseline to 12
Perceived Deficits Questionnaire
Questionnaire asking about mental clairty
Time frame: Baseline to 12
Anxiety Score -Hospital Anxiety and Depression Survey
Survey asking about mood and daily activities. Change in anxiety score for the hospital anxiety and depression scale score based on the responses.
Time frame: change from baseline to 12 months
Depression score -Hospital Anxiety and Depression Survey
Survey asking about mood and daily activities. Change in depress score for the hospital anxiety and depression scale score based on the responses.
Time frame: change from baseline to 12 months
MS Clinical symptoms over time
Medical record abstraction of function and MS symptoms from progress notes, (worse, stable, improved)
Time frame: baseline to 6 months
MS Clinical symptoms over time
Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved)
Time frame: baseline to 12 months
MS Clinical symptoms over time
Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved)
Time frame: baseline to 18 months
MS Clinical symptoms over time
Medical record abstraction of function and MS symptoms from progress notes (worse, stable, improved)
Time frame: baseline to 24 months
Dietary intake
Automated 24 hour dietary intake questionnaire completed online that asks questions about beverages and foods consumed in the prior 24 hours.
Time frame: baseline to 12 months
Plan to share: No
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting→
Terry L. Wahls