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ACTIVE NOT RECRUITING
NCT04009005
NA

Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

Sponsor: Terry L. Wahls

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2020-05-01

Completion Date

2027-09-01

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

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

Locations (1)

University of Iowa

Iowa City, Iowa, United States