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Therapeutic Diet and Lifestyle for Multiple Sclerosis

N/A

Waitlist Available

Led By Terry L Wahls, MD

Research Sponsored by Terry L. Wahls

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Awards & highlights

Study Summary

This trial will compare two groups of people with MS: those who only receive a diet and therapeutic lifestyle treatment, and those who receive usual care (which may include disease-modifying drugs). The study will look at changes in quality of life and clinical outcomes.

Who is the study for?

This trial is for individuals in the lower 48 states of the US who have been recently diagnosed with Clinically Isolated Syndrome (CIS) or Relapsing-Remitting Multiple Sclerosis (RRMS). They must be willing to share clinical notes and get approval from their neurologist. People with moderate/severe mental impairment, contraindications to MRI, certain medication use, or specific medical conditions are excluded.Check my eligibility

What is being tested?

The study is testing whether a therapeutic lifestyle approach focusing on diet, stress reduction, and exercise can match or outperform standard drug treatments for reducing MS symptoms and improving life quality. It's a virtual study comparing these non-drug interventions against usual care in newly diagnosed CIS or RRMS patients.See study design

What are the potential side effects?

Since this trial involves dietary changes and lifestyle adjustments rather than medications, side effects may include typical reactions to diet change such as digestive discomfort. Stress reduction techniques and exercise are generally beneficial but could cause muscle soreness or emotional responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MS 54 Quality of Life scale mental health score

MS 54 Quality of Life scale physical health score

Secondary outcome measures

Anxiety Score -Hospital Anxiety and Depression Survey

Depression score -Hospital Anxiety and Depression Survey

Dietary intake

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Therapeutic LifestyleExperimental Treatment1 Intervention

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.

Group II: Usual careActive Control1 Intervention

Participants will receive usual care from their treating neurologist

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Terry L. WahlsLead Sponsor

5 Previous Clinical Trials

351 Total Patients Enrolled

4 Trials studying Multiple Sclerosis

351 Patients Enrolled for Multiple Sclerosis

Terry L Wahls, MDPrincipal InvestigatorUniversity of Iowa

4 Previous Clinical Trials

251 Total Patients Enrolled

3 Trials studying Multiple Sclerosis

251 Patients Enrolled for Multiple Sclerosis

Media Library

Therapeutic diet and lifestyle Clinical Trial Eligibility Overview. Trial Name: NCT04009005 — N/A

Multiple Sclerosis Research Study Groups: Usual care, Therapeutic Lifestyle

Multiple Sclerosis Clinical Trial 2023: Therapeutic diet and lifestyle Highlights & Side Effects. Trial Name: NCT04009005 — N/A

Therapeutic diet and lifestyle 2023 Treatment Timeline for Medical Study. Trial Name: NCT04009005 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement for participation in this trial greater than 45 years old?

"The eligibility criteria for this medical trial is limited to individuals aged 18 to 55. There are 416 trials available for minors and 1376 studies open to seniors."

Answered by AI

Are there still vacant positions available for this research project?

"According to information found on clinicaltrials.gov, this trial is not currently looking for participants - the study was first posted on May 1st 2020 and its most recent update happened December 14th 2021. Although no recruitment is taking place now, 1942 other studies are actively seeking volunteers."

Answered by AI

What goal is the investigation hoping to accomplish?

"The primary intent of this research, which will be observed over a 12 month change from baseline period, is to assess the MS 54 Quality of Life scale physical health score. Additionally, Magnetic Resonance Imaging (MRI) of CNS data, medical record abstraction for function and symptoms changes in MS patients, as well as 24 hour dietary intake questionnaires are all part of the secondary objectives."

Answered by AI