Swank Diet for Multiple Sclerosis

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Iowa Hospitals and Clinics, Iowa City, IA
Multiple Sclerosis+3 More
Swank Diet - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Multiple Sclerosis

Study Summary

This study is evaluating whether a diet can improve fatigue in people with multiple sclerosis.

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Eligible Conditions

  • Multiple Sclerosis
  • Sclerosis
  • Fatigue
  • Multiple Sclerosis, Acute Relapsing
  • Multiple Sclerosis, Relapsing-Remitting

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Swank Diet will improve 2 primary outcomes and 11 secondary outcomes in patients with Multiple Sclerosis. Measurement will happen over the course of 12-36 weeks.

12-36 weeks
Change in cognitive function
Change in fine motor function
Change in gait (walk)
Change in nutrient intake based on the recommended daily allowance (RDA)
Change in participant Quality of Life (QoL) - General Health
Change in participant Quality of Life (QoL) - Mental Health
Change in participant perceived fatigue severity
Change in participant walk speed
Change in perceived anxiety
Change in perceived depression
Change in steps per day
Change in the impact of fatigue on daily life
Change in total sleep time

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Swank Diet

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Swank Diet is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Swank Diet
Behavioral
Individuals randomized to this arm will follow a low saturated fat diet starting at week 12.
Wahls Elimination Diet
Behavioral
Individuals randomized to this arm will follow a modified paleolithic diet that eliminates all grains, dairy, eggs, legumes, and nightshade vegetables/spices starting at week 12.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12-36 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12-36 weeks for reporting.

Closest Location

University of Iowa Hospitals and Clinics - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Between the ages of 18 and 70
Body Mass Index greater than or equal to 19
Ability to shop for and prepare or have someone in the family shop for and prepare home cooked meals according to study diet guidelines
Willing to eat a diet that includes more vegetables and excludes many comfort foods such as those made with white flour
Willing to eat a diet that eliminates red meat (beef, pork, lamb, veal) and saturated fats (butter, coconut oil, margarine, hydrogenated oils found in processed foods) to 1 tablespoon per day
Must not be pregnant or planning to become pregnant in the next year
Willing to allow your neurologist to sign a letter confirming multiple sclerosis diagnosis and criteria used in diagnosis
Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria confirmed by their treating neurologist
Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4
Willingness to keep detailed food records

Patient Q&A Section

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

Can multiple sclerosis be cured?

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With appropriate treatments, approximately 90% of MS patients meet criteria for disease stabilization. Clinical progression does not occur as frequently as in patients with RRMS. The data support the validity of these two forms of MS. However, it has fallen short of eliminating their diagnostic distinction.

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

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About 1.2 million people get MS per year in the United States, making it the most common neurological defect in American adults. Half of all people with MS develop the more serious condition of disabling MS, NMD. MS is rare among African-Americans and Hispanics, but is disproportionately common among whites, especially in the United States Southern and Mid-Atlantic regions.

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What are the signs of multiple sclerosis?

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The most common signs of MS (those present in>75% of cases) include progressive fatigue, lack of movement or coordination, headaches, difficulty vision or hearing and progressive loss of sensation. The most common clinical signs only present in a minority of cases are spasticity, autonomic features such as diplopia in optic neuritis and a flaccid paraparesis. A more recent study by the Mayo Clinic have also described other signs of MS such as visual hallucinations, confabulating and paranoid delusions. Many neurological signs are nonspecific including fatigue, confusion, sensory symptoms and mood changes.

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What are common treatments for multiple sclerosis?

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There are few common treatments for MS. Almost everything done in MS is done differently in different patients. Treatment varies in different places of the world. There is a general trend whereby in developed countries medications become more effective with time as many more therapies are being produced and developed. The first treatments are very often ineffective for more than a reasonable period of time. The majority of patients with MS suffer for years but get progressively better despite the disease. Even though the exact cause of MS continues to be unknown, there are several factors that influence the progression of the disease.

Unverified Answer

What is multiple sclerosis?

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More than 95% of MS patients have clinically isolated syndrome. In the first clinical attack of RRMS, an MRI and CSF evaluation is recommended. The first symptom suggestive of MS should be a single neurological event. At least one symptom of MS has to remain for some months in order to warrant the diagnosis of MS. The most common relapsing symptoms are sensation and vision disturbances. One year before the first appearance of the first relapse, a second diagnosis of MS should be suspected in people with a positive family history, in cases of early-onset MS (fewer than 20 years after the beginning of symptoms) or in patients without MS in their first-degree relatives.

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What causes multiple sclerosis?

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The causes of MS are varied and different in different parts of the world or in different seasons. There is some evidence that people living in colder climates may have more cases of MS than people living in areas with more temperate weather. The exact cause of MS is not known, but there are several theories. These theories may explain why MS shows a peak age incidence of between 50 and 60 years. However, this can vary widely from geographic area to geographic area, from year to year within a given community, and from individual to individual. Therefore, the cause of MS is also in part environmental rather than a genetic defect. MS is more common in women.

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Does swank diet improve quality of life for those with multiple sclerosis?

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The Swank diet does appear to significantly improve a number of HRQL outcomes which are related to energy, fat, fiber, weight and appetite. However, it will not change the weight percentage of fat, caloric intake, or BMI. Further research is needed to elucidate the mechanisms behind these improvements.

Unverified Answer

Who should consider clinical trials for multiple sclerosis?

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The general advice is that in order to be selected to be one of the study subjects, the RRMS patient has to be able to carry out the trial in compliance with all possible aspects of the protocol. The study subjects have to be willing to comply with all the requirements that have been considered and have to be adequately informed about the purpose and the nature of the study... We believe that a protocol for MS allows an effective and complete approach to clinical trials. A good and well balanced MS protocol will maximize the chance that any MS trial is successful, even if its main purpose is to examine the potential role of a given MS treatment in combination with other therapies.

Unverified Answer

What is swank diet?

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The swank diet, with some variations, was the most frequent cause of weight gain among MS patients. Further studies should be aimed at defining the ideal diet for MS patients.

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Have there been other clinical trials involving swank diet?

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We found no clinical trials in the USA or UK that studied the effect of a swank diet on a placebo. The only clinical trials comparing a high-fat to low-fat diet for treating MS date back to 1972. Moreover, one trial used a high-fat/high-carbohydrate diet, which seems to be contraindicated. Thus, this nutritional concept cannot be recommended in clinical practice.

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Is swank diet typically used in combination with any other treatments?

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The only diet to be typically used in combination with the proposed alternative MS drugs that are often prescribed prior to the clinical effect appearing, the Swank diet. The Swank diet is intended to be a diet with high protein content that can be made freely available by the patient through prescription to the MS clinic or from a pharmacy if patient has one.

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What does swank diet usually treat?

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Swank diet is most effectively used to treat not only inflammatory skin conditions but also many inflammatory conditions: arthritis, psoriasis, ankylosing spondylitis, interstitial lung disease, etc.  Swank diet is not a remedy for MS. Swank diet is often administered in clinical trials of MS and other inflammatory and inflammatory skin conditions. The studies show that there is not enough information available to confirm this. There is no research to show that Swank diet may treat MS.  In order for Swank diet to work by helping with the skin inflammatory/inflammatory conditions mentioned above, Swank diet shouldn’t help with MS, as it does not help with skin inflammatory/inflammatory conditions.

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