Investigation of the Effect of the MIND Diet on Disease Symptoms in Patients With MS

NCT07057999 | Completed DMC

• 1 other identifier: Decision number 2025/643
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Diet Therapy; Body Composition; Randomised Controlled Trial; Brain Fog; Fatigue Syndrome, Chronic; Quality of Life (QOL)

Outcome Measures

Primary Outcomes (3)

• The Effect of the MIND Diet on Quality of Life

  -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.

  12 weeks from the start of the intervention

• Effect of the MIND diet on fatigue in MS patients

  -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.

  12 weeks from the start of the intervention

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

  -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.

  12 weeks from the start of the intervention

Secondary Outcomes (2)

• 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

Study Arms (2)

intervention group

ACTIVE COMPARATOR

MIND Diet Program

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

control group

ACTIVE COMPARATOR

Traditional Healthy Nutrition Program

Behavioral: Traditional healthy nutrition program specific to Turkey

Interventions

MIND Diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) BEHAVIORAL

The MIND diet consists of 15 components. While the first 10 of the components are considered healthy for the brain, the last 5 are considered unhealthy. The MIND diet portion and consumption frequency recommendations are as follows; olive oil consumption ≥ 48 g/day; oil seeds and nuts ≥ 5 servings/week; green leafy vegetables ≥1 serving/day; cooked vegetables ≥1 serving/day; whole grains ≥3 servings/day; legumes 3 servings/week; red fruits such as blueberries and strawberries ≥2 servings/week; poultry ≥2 servings/week; fish and seafood ≥1 serving week; red wine 1 glass/day; red meat ≤4 servings/week; butter ≤10 g/day; bakery products \<5 servings/week; fast food \<1 serving/week. Patients assigned to this group will be given a diet program based on isocaloric, MIND diet principles, which they will be asked to follow for 12 weeks.

Also known as: MIND diet, DASH, Mediterranean diet

intervention group

Traditional healthy nutrition program specific to Turkey BEHAVIORAL

There are no prohibited foods in the traditional Türkiye-specific nutrition recommendations included in the TÜBER 2022 report, but there are foods that are recommended to be restricted or increased. According to the healthy nutrition program, 3 portions/day from the milk and dairy products (milk, yogurt, kefir, cheese) group; 2.5-3 portions/day from the meat, chicken, fish, eggs, legumes, oilseeds and nuts group; 2.5-4 portions/day from the vegetable group; 2-3 portions/day from the fruit group; 3-7 portions/day from the bread and cereal group; 3-4 portions/day from the fat group and finally, simple sugar consumption is recommended as a maximum of 10% of total energy. An isocaloric diet will be prepared according to the body composition and eating habits of the patients and they will be asked to follow it for 12 weeks.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Betul Uner: lead

Study Sites (1)

Muğla Sıtkı Koçman University/Muğla Training and Research Hospital Neurology Polyclinic

Muğla, Mentese, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Mental Fatigue; Fatigue Syndrome, Chronic

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, MSc

Model Details: The planned study will be conducted in the Neurology Outpatient Clinic of Muğla Education and Research Hospital and will use a parallel-group, open-label, randomized controlled trial design. Randomization, where each participant has an equal chance of being assigned to the intervention group, is an effective way to prevent the risk of selection bias. Block randomization will be used to determine the intervention and control groups in the planned study.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 10, 2025
• Study Start: June 16, 2025
• Primary Completion: November 27, 2025
• Study Completion: December 27, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TU (1)