NCT04009005Active, not recruiting
Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 1 Jul 2019
- Start date
- 1 May 2020
- Primary completion date
- 1 Aug 2022
- Lead sponsor
- Terry L. Wahls
- Diseases
- Multiple sclerosis
- NCT number
- NCT04009005
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 1 May 2020 to the primary completion date, 1 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 1\) A diagnosis of clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) or CIS according to the 2010 McDonald's criteria, confirmed by the treating neurologist within 12 months of completing the first study visit. and having received a recommendation to begin disease modifying treatment (DMT)2) Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.3) Must reside within the lower 48 states within the United States.4) Agreement by the treating neurologist that the patient may enroll in the study.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.