Therapeutic diet and lifestyle for Clinically Isolated Syndrome (CIS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa, Iowa City, IA
Clinically Isolated Syndrome (CIS)+5 More
Therapeutic diet and lifestyle - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

See full description

Eligible Conditions

  • Clinically Isolated Syndrome (CIS)
  • Relapsing Remitting Multiple Sclerosis (RRMS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Therapeutic diet and lifestyle will improve 2 primary outcomes and 5 secondary outcomes in patients with Clinically Isolated Syndrome (CIS). Measurement will happen over the course of change from baseline to 12 months.

baseline to 12 months
Dietary intake
baseline to 24 months
MS Clinical symptoms over time
Magnetic Resonance Imaging of CNS
Month 12
Anxiety Score -Hospital Anxiety and Depression Survey
Depression score -Hospital Anxiety and Depression Survey
MS 54 Quality of Life scale mental health score
MS 54 Quality of Life scale physical health score

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Usual care
1 of 2
Therapeutic Lifestyle
1 of 2
Active Control
Experimental Treatment

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Therapeutic Diet And Lifestyle is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Therapeutic Lifestyle
Behavioral
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.
Usual careParticipants will receive usual care from their treating neurologist

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 24 months for reporting.

Closest Location

University of Iowa - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received newly diagnosed for Clinically Isolated Syndrome (CIS) or one of the other 5 conditions listed above. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.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.

Patient Q&A Section

How many people get multiple sclerosis a year in the United States?

"We found that 1 in every 3 Americans would experience that disease at some time in their life. The risk of developing the disorder was lowest in the first decade of life and rose steadily until around age 75." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple sclerosis?

"Patients of any age may be treated with corticosteroids. There is also significant interest in newer agents for treatment of MS. There is a clear absence of treatments for MS that are available outside of North America." - Anonymous Online Contributor

Unverified Answer

What causes multiple sclerosis?

"The cause of MS is not known, and there are numerous theories. The prevailing idea is that the disease results from “demyelination” of the white matter of the brain, but more recent research suggests that the process can go on in the absence of white matter damage; the presence of “tumour-like” lesions; or immune-based damage to other parts of the brain; or a combination of these. We would probably have better knowledge if it were not very difficult to detect these abnormalities. There are numerous possible explanations for the disease. To date, none have been proved to be correct, and there will probably always be more research necessary in this field." - Anonymous Online Contributor

Unverified Answer

Can multiple sclerosis be cured?

"The most effective therapy in MS is probably to try to slow the progressive course of MS and to try improving the quality of life. If, however, the condition is not so severe that the quality of life is severely affected, the treatment to try to prevent, or even treat, fatigue, depressive symptoms, and other disability-related symptoms is worthwhile." - Anonymous Online Contributor

Unverified Answer

What is multiple sclerosis?

"Multiple sclerosis is a disease that mainly affects the central nervous system (CNS). It can affect many systems throughout the body and over time, cause disabling symptoms, and, in many cases, result in disability.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple sclerosis?

"A complete clinical examination in people with an MS diagnosis is essential for detecting a number of the early signs of the disease. These include abnormal eye movements, unsteady walking, decreased vision, fatigue, mood swings and decreased cognition.\n" - Anonymous Online Contributor

Unverified Answer

Does multiple sclerosis run in families?

"These data indicate no evidence for linkage of MS to a chromosome region containing a known MHC gene, such as a gene encoding major histocompatibility complex class II or TNF or IFN regulatory factor 1." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving therapeutic diet and lifestyle?

"Therapeutic diet and lifestyle may have a potentially beneficial effect in the management of MS. However, the lack of information may lead clinicians to consider placebo effects." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets multiple sclerosis?

"Which I am too late to say but that is the most recent survey so far...about 10years ago, so I'm still researching to find out if that's the most current information available. (the average age at onset of MS has also been changing. It used to be about 27 years, then in the past decade this has been 20.5. Now that's not good... ) My feeling is that perhaps it's actually not going to change. In fact, I think people are going to be MS'ing as they have for more than 30years and still are..." - Anonymous Online Contributor

Unverified Answer

Is therapeutic diet and lifestyle safe for people?

"We conclude that an enriched dietary pattern and a healthy lifestyle cannot be recommended. The health benefits achieved with a balanced diet are not due to improvements in metabolic parameters of participants with MS." - Anonymous Online Contributor

Unverified Answer

Is therapeutic diet and lifestyle typically used in combination with any other treatments?

"Overall, we found that dietary and lifestyle modification were relatively infrequently added to existing MS treatments, and usually did not contribute significantly to the therapeutic effect of the therapeutic regimen." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in therapeutic diet and lifestyle for therapeutic use?

"Dietary and physical interventions have made significant progress in the treatment of MS. Diet is considered an adjuvant; some patients may benefit from nutritional intervention, either with nutritional supplements or with nutritional programs. MS diet should be individualized and should be used in rehabilitation clinics. There are many possibilities for improvement of diet. It is time to get closer to patients, know how they eat, which foods they get, what is their dietary approach (including quantity and quality of food), which supplements are used, etc. It is important to understand how the new therapeutics will affect the dietary program; some of them will be complementary." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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