Multiple SclerosisNCT05777629
Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with MS between the ages of 18-65
Who may be able to join
- Being between the ages of 18-65
- Having been diagnosed with multiple sclerosis
- Having voluntarily agreed to participate in the research
- Absence of exclusion criteria
Who cannot join
- Being under the age of 18 and over the age of 65
- Being pregnant or in the postpartum period during the research
- Having an attack during the research
- Active infection
- Having another disease that prevents him from doing physical activity
- Having a disease that requires a special diet
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Mediterranean Diet, Quality of Life, Walking
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
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.
Measured: 1 months
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
Measured: 2 months
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start28 Feb 2021
- Primary completion30 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezihe Otay Lule, University of Gaziantep
- Investigators
- Yasemin EKMEKYAPAR FIRAT, Principal investigator, Sanko UniversityMünife NEYAL, Principal investigator, Sanko Universityİpek KATİRCİ KİRMACİ, Principal investigator, Kahramanmaras Sutcu Imam UniversityNezihe OTAY LULE, Principal investigator, Gaziiantep University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777629
- Sponsor's protocol ID
- nol
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Compliance to Mediterranean Diet, Impacts on Walking and Quality of Life in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05777629
- Acronym / sponsor ID
- nol
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Mediterranean Diet, Quality of Life, Walking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with MS between the ages of 18-65
Key inclusion criteria (4 listed)
- Being between the ages of 18-65
- Having been diagnosed with multiple sclerosis
- Having voluntarily agreed to participate in the research
- Absence of exclusion criteria
Key exclusion criteria (6 listed)
- Being under the age of 18 and over the age of 65
- Being pregnant or in the postpartum period during the research
- Having an attack during the research
- Active infection
- Having another disease that prevents him from doing physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mediterranean Diet Compliance Status
Time frame: 1 year
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).
Quality of Life Of Multiple Sclerosis Patients
Time frame: 1 months
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.
Impacts on Walking
Time frame: 2 months
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
Expanded Disability Status Scale
Time frame: 1 year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin EKMEKYAPAR FIRAT principal investigator
Sanko University
Münife NEYAL principal investigator
Sanko University
İpek KATİRCİ KİRMACİ principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mediterranean Diet Compliance Status (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.