Clinical trial NCT05777629: Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis
Official title: Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Mediterranean Diet
Quality of Life
Walking
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with MS between the ages of 18-65

Brief summary: Multiple Sclerosis (MS) is an autoimmune disease characterized by inflammation, demyelination and axon damage. Affecting approximately 2.5 million individuals around the world and seen mostly in young adults, MS can cause different levels of disability in functional activities, cause limitations in social and professional life, and impair quality of life. Multiple sclerosis is thought to be an autoimmune disease that develops on the basis of genetic predisposition and environmental factors. Nutritional habits and physical activity are important environmental factors. These can be effective in the course of MS and change the quality of life. Compatibility of nutrition with the Mediterranean diet and providing adequate physical activity may be beneficial in increasing physical and mental well-being in general, and therefore the quality of life of the person.

In our country, there is not enough information about the ongoing nutritional habits and physical activity levels of MS patients in their daily lives, and quality of life studies are limited. Our limited knowledge on these issues narrows the possibility of movement in an area that can be corrected in MS patients and thus have a positive impact on their quality of life. The aim of this study is to determine compliance with the Mediterranean diet, the tendency to use various nutritional supplements, physical activity habits, walking-related problems and quality of life in MS patients and to evaluate whether there is a significant relationship between these parameters.

Detailed description: Clinical studies examining the effects of various dietary patterns on MS are ongoing, and evidence is still lacking regarding the use of any specific dietary therapy for individuals with MS. In general, individuals living in high-income western countries where the disease is more common; They lead a sedentary life, are less exposed to sunlight, and are fed a high-energy diet rich in animal-derived saturated fats and refined sugar.

The Mediterranean diet is a nutritional model that is universally thought to improve health, and it is known that the Mediterranean diet has beneficial effects in the prevention and treatment of chronic diseases.The major difference between the Mediterranean diet and the Western-style diet is the source and amount of dietary fat and carbohydrates. The Mediterranean diet is rich in foods containing monounsaturated fat (especially omega-3), antioxidant vitamins and minerals (vitamins A, C, E, folic acid, selenium, zinc, calcium), which are thought to have positive effects on the prevention and course of MS.

Preferring vegetable oils instead of animal fats in Mediterranean type diet, preferring fish instead of red meat consumption, preferring low-fat / fat-free milk and dairy products, limiting the intake of simple sugar and refined carbohydrates, increasing the consumption of fruits and vegetables rich in pulp and antioxidants. It is thought that this type of nutrition may positively affect the course and treatment of immune diseases by reducing inflammation.

Although there is no effective clinical evidence for the application of nutritional support as complementary therapy in MS patients, it is known that patients often use various nutritional supplements to reduce symptoms that negatively affect their quality of life. It is also important to determine the frequency of current nutritional support use in order to prevent unconscious use of nutritional support in the group.

Because the most common symptoms of MS are muscle weakness, individuals with MS are often less physically active than age-matched adults

All these negativities result in decreased functional activities, loss of mobility and balance problems.

Walking and, in a broader sense, mobility are functions that are frequently affected in MS and have a high negative impact on quality of life. Gait problems are not uncommon in MS, and it is reported that a significant portion of individuals in this group are adversely affected by their daily living activities.

The aim of this study is to determine compliance with the Mediterranean diet, the tendency to use various nutritional supplements, physical activity habits, walking-related problems and quality of life in MS patients and to evaluate whether there is a significant relationship between these parameters.

Eligibility criteria: Inclusion Criteria:

1. Being between the ages of 18-65
2. Having been diagnosed with multiple sclerosis
3. Having voluntarily agreed to participate in the research
4. Absence of exclusion criteria

Exclusion Criteria:

1. Being under the age of 18 and over the age of 65
2. Being pregnant or in the postpartum period during the research
3. Having an attack during the research
4. Active infection
5. Having another disease that prevents him from doing physical activity
6. Having a disease that requires a special diet

Primary outcomes:
measure: Mediterranean Diet Compliance Status
timeFrame: 1 year
measure: Quality of Life Of Multiple Sclerosis Patients
timeFrame: 1 months
measure: Impacts on Walking
timeFrame: 2 months
measure: Expanded Disability Status Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: UGaziantep
Study officials:
affiliation: Sanko University
name: Yasemin EKMEKYAPAR FIRAT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanko University
name: Münife NEYAL
role: PRINCIPAL_INVESTIGATOR
affiliation: Kahramanmaras Sutcu Imam University
name: İpek KATİRCİ KİRMACİ
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziiantep University
name: Nezihe OTAY LULE
role: PRINCIPAL_INVESTIGATOR
References: