Adherence to Mediterranean Diet and Cardiovascular Health in Multiple
Adherence to Mediterranean Diet and Cardiovascular Health in Multiple Sclerosis Female Patients: a Case Control Study
What it found
We found no results in the registry or in papers.
This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Lifestyle intervention
What it measured
Main measures
MedDietScore
3 months
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 and over
Show the full criteria
Inclusion criteria
Inclusion Criteria: adult women (≥ 18 years) with relapsing-remitting MS diagnosis; patients should follow a standardized immunomodulatory therapy or other disease-modifying therapy for at least 6 months; the patient should be able to walk without aid or work a full day in a position of average difficulty, as indicated by scores of Expanded Disability Status Scale (EDSS) \< 4.5; patients with at least one lesion on brain MRI and/or at least one relapse in the past two years. Exclusion Criteria: women with concomitant illness (e.g. malignancy, infections, malabsorption, heart-, liver- or renal failure); patients who changed treatment during or ≤ 6 months before the start or the trial; psychiatric conditions, alcoholism, drug addiction; using vitamin or mineral supplements during or ≤ 6 months prior to screening; following a vegan diet ≤ 5 years prior to screening or using weight loss medications; pregnant or lactating women.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple sclerosis (MS) is a chronic immune-mediated neurodegenerative disease that affects the central nervous system (CNS). The exact pathophysiology of MS remains unclear; it is suggested that the inflammatory state persists under a genetic-energetic-environmental complex causing a variety of clinical symptoms depending on the neuroanatomical location of MS lesions. The age of MS onset ranges between 20 and 40 years. MS is usually initiated as a relapsing-remitting disease, which may last several years to decades affecting females twice as often as males. Dietary factors may have an important impact on MS. Data from human and animal studies indicate that saturated fatty acids (SFA), the major fat type of animal foods in the "Western" diet, increase MS susceptibility. The Mediterranean dietary (MedDiet) pattern is hypothesized to be beneficial to MS patients protecting against the development cardiovascular diseases. However, little is known about the cardiovascular effects of the MedDiet on MS patients. Consequently, the aim of the present randomized, case control study was to investigate the effects of MedDiet on cardiovascular factors in women with relapsing-remitting MS after a 3-month intervention period.
Papers
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History
Started
Dec 2020
Main results due
Feb 2021
Finished
Mar 2021