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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.