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Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

NCT04009005 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

  • Clinically Isolated Syndrome
  • Relapsing Remitting Multiple Sclerosis

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

Sponsors & Collaborators

  • Terry L. Wahls

    lead OTHER

Principal Investigators

  • Terry L Wahls, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-08-01
Completion
2027-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009005 on ClinicalTrials.gov