跳至主要内容
临床试验/NCT07057999
NCT07057999已完成不适用

Effects of the MIND Diet on Fatigue, Quality of Life, and Brain Fog in Patients With Multiple Sclerosis: A Randomized Controlled Trial

Betul Uner1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
The Effect of the MIND Diet on Quality of Life

研究概览

简要总结

The planned parallel group, randomized controlled study design will be used to determine the effects of the MIND diet applied to MS patients on fatigue, quality of life, technological function and brain fog and to contribute to the scientific literature. This study document will also determine the scope of the MIND diet for MS details. The regular questions it aims to answer are as follows:

  • Is the MIND diet applied to MS treatments effective on quality of life compared to traditional healthy nutrition?
  • Is the MIND diet applied to MS treatments effective on fatigue compared to traditional healthy nutrition therapy?
  • Is the MIND diet applied to MS treatments effective on brain fog compared to traditional healthy nutrition therapy?

In this study, the MIND diet will be controlled with a traditional healthy nutrition program specific to Türkiye to evaluate the effect of the MIND diet on MS disease.

Participants:

  • Adhere to your specially prepared diet for 3 months
  • Participate in online meetings with researchers every week to check compliance with the diets
  • Visit the hospital for a check-up at the end of 3 months The collected study data will be analyzed in a computer environment using the Statistical Package for Social Sciences (IBM, SPSS, version 29.0) software, and p<0.05 is accepted as the significance level.

详细描述

Multiple Sclerosis (MS) is defined as an autoimmune disease of the central nervous system that causes myelin loss and axonal damage and is characterized by inflammation. MS can also occur as acute optic neuritis, brainstem syndrome, pyramidal system demyelination and/or spinal cord syndromes. In addition to neurological symptoms such as vision loss, weakness, numbness, difficulty walking and dysesthesia due to demyelination occurring during the formation of the disease, atypical symptoms such as fatigue, depression and cognitive disorders are also observed. Although early and accurate diagnosis of MS is essential, diagnosis is based on the presence of clinical symptoms and findings on magnetic resonance imaging (MRI), which is highly sensitive in detecting characteristic central nervous system lesions. McDonald 2017 criteria are used in the diagnosis of the disease.

There are four clinically defined types of the disease. The types of MS are; relapsing-remitting MS, which constitutes approximately 85% of cases, primary progressive MS, which constitutes 10-20% of cases, secondary progressive MS, and clinically isolated syndrome. In patients with relapsing-remitting MS, the transmission of nerve impulses is affected during relapses, while the course of the disease and symptoms tend to improve or improve during remission. When relapses increase, progressive neural dysfunction occurs, and when remission is not achieved, progressive neurological damage occurs. This condition is defined as secondary progressive MS. In order to diagnose primary progressive MS, the disability status that continues for at least one year must be progressive. However, distinguishing between primary progressive MS and secondary progressive MS is often challenging. Although the course of the disease varies greatly depending on the type, many people develop irreversible disability, and MS continues to be the leading cause of neurological disability in young adults. The disability levels of individuals with MS are determined by the Expanded Disability Status Scale (EDSS). EDSS is a scale used worldwide in the evaluation and follow-up of neurological examinations of patients. The EDSS score ranges from 0 to 10. A score of 0 means "normal neurological examination, no disability", while a score of 10 means "death due to MS".

Genetic factors, microbial and viral infections, smoking, serum vitamin D levels, obesity and nutritional habits are effective in the development of MS. Although the immune system seems to have a major effect on protection from MS, it is stated that the innate or acquired immune system may be effective in the development and occurrence of the disease. Although the mechanism is not clearly explained, it is stated that the disease may develop due to an autoimmune response that occurs as a result of damage to the blood-brain barrier caused by antigens formed against neurodegenerative diseases such as Alzheimer's or any viral infection.

MS is more common and economically burdensome in high-income countries such as Western Europe and North America, which are farthest from the equator. It is known that Western-style nutrition is dominant in these countries and that there is insufficient exposure to sunlight. The average age of onset of the disease has been determined as 32. Although it is more common in young adults and women, the female/male patient ratio has been reported to be between 1.5:1 and 2.5:1. It is estimated that there are 70 thousand MS patients in Turkey. It is known that approximately 2.8 million people have MS worldwide. The prevalence of the disease is determined as 35.9 MS patients per 100,000 people.

There is currently no known definitive treatment for the disease. However, disease-modifying treatments (DMTs) such as interferon beta-1a, interferon beta-1b, peginterferon beta-1a, glatiramer acetate, dimethyl fumarate, teriflunomide, natalizumab, fingolimod, cladribine, ocrelizumab and alemtuzumab are used to control the frequency of relapses, disability and progression of symptoms. Lifestyle changes applied in addition to DMTs can also improve the course of the disease. The aim of lifestyle changes applied to MS patients is to improve quality of life, reduce perceived fatigue and disability, and help improve the effects of brain fog that has come to the fore after the Covid-19 outbreak.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult MS patients between the ages of 18-65 diagnosed according to the 2017 McDonald criteria
  • •Having been diagnosed with MS at least three months ago; patients are called for routine check-ups in the first and third months after starting treatment, as liver function tests and/or hemogram values may be impaired due to the treatment they started when they are newly diagnosed with MS. For this reason, it was planned to include patients whose check-ups were completed and no unexpected changes were observed in the blood parameters table due to the medication.
  • •No DMT change in the last 6 months
  • •Patients who use their medications regularly
  • •Not using nutritional support or supplements
  • •Patients with an EDSS score of ≤6
  • •Patients with a body mass index (BMI) between 18.5-24.9 kg/m2

排除标准

  • •MS patients who are pregnant or lactating
  • •Having another chronic metabolic disease and/or having had surgery in the last 3 months
  • •MS patients with limb deficiency
  • •MS patients on a special diet
  • •Patients using antidepressants and/or mood stabilizers
  • •Having had an attack and/or receiving steroid treatment in the last month

研究组 & 干预措施

intervention group

Active Comparator

MIND Diet Program

干预措施: MIND Diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) (Behavioral)

control group

Active Comparator

Traditional Healthy Nutrition Program

干预措施: Traditional healthy nutrition program specific to Turkey (Behavioral)

结局指标

主要结局

The Effect of the MIND Diet on Quality of Life

时间窗: 12 weeks from the start of the intervention

-Multiple Sclerosis Quality of Life-54 Questionnaire consists of 12 subscales (I-Physical Health, II-Role limitations due to physical problems, III-Role limitations due to emotional problems, IV-Emotional well-being, V-Energy/fatigue, VI-Health perceptions, VII-Social functioning, VIII-Cognitive functioning, IX-Health distress, X-Sexual functioning, XI-Changes in health, XII-General quality of life). The scores of each subscale range from 0 to 100, with higher scores indicating better quality of life. MIND will be used to evaluate the role of the dietary intervention on quality of life.

Effect of the MIND diet on fatigue in MS patients

时间窗: 12 weeks from the start of the intervention

-Modified Fatigue Impact Scale, total score ranges from 0-84. Increasing score is associated with increased fatigue. It will be used to evaluate the role of MIND diet intervention on fatigue.

The effect of the MIND diet on brain fog in MS patients

时间窗: 12 weeks from the start of the intervention

-Brain Fog Scale, total score ranges from 30-150. An increase in score indicates an increase in brain fog level. It will be used to evaluate the effect of MIND diet on brain fog.

次要结局

  • The effect of the MIND diet on blood parameters(At the end of 12 weeks after the start of the intervention)
  • Effect of the applied MIND diet on body composition(After 12 weeks of MIND diet or healthy eating program application)

研究者

发起方
Betul Uner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Betul Uner

Lecturer, MSc

Muğla Sıtkı Koçman University

研究点 (1)

Loading locations...

相似试验