Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05777629
• Other study ID #: nol
• Status: Active, not recruiting
• Start date: February 28, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: June 1, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Turkey	UGaziantep	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mediterranean Diet Compliance Status	The 14-item Mediterranean Diet Adaptation Scale (PREDIMED) will be used to determine the adaptation status of individuals to the Mediterranean diet. In this scale, there are a total of 14 questions, 12 of which are about food consumption frequency and 2 are about food consumption habits. The score given for each question is 0 or 1 point. Then the scores are summed and the score is evaluated as =5 (low agreement), 6-9 (moderate agreement), and =10 (high agreement).	1 year
Primary	Quality of Life Of Multiple Sclerosis Patients	The quality of life of individuals will be determined by the Multiple Sclerosis International Quality of Life Scale. It is evaluated between 0-124 points in total. An increase in the total score is associated with a higher quality of life.	1 months
Primary	Impacts on Walking	The 12-item Ms Gait Scale will be used to determine the gait impact. 12-item MS Gait Scale: It is a 12-item questionnaire that questions the effect of walking in MS. The difficulties experienced by individuals during walking activity in the last 2 weeks are questioned. Each item contains 5 points (1; not at all impressed, 5; totally impressed). Lower scores indicate better gait impairment	2 months
Primary	Expanded Disability Status Scale	The disability status of the patients will be determined using the Expanded Disability Status Scale (EDSS). The EDSS scale measures disability and neurological symptoms in MS patients. A score between 0 and 10 is given on the scale. 0 indicates no disability or disorder, 10 indicates MS-related death	1 year