Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis

NCT ID: NCT06546033

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2026-12-02

Brief Summary

When the literature was reviewed, there is no study in which the effects of intermittent fasting and Mediterranean diet on quality of life, sleep, circadian rhythm and appetite hormones leptin and ghrelin levels in MS patients were evaluated and the two diet types were comparatively examined in terms of all these parameters.

Detailed Description

Multiple Sclerosis (MS) is the most common chronic inflammatory disease affecting young adults between the ages of 20-40 years, which causes irreversible neurological damage and symptoms and is influenced by genetic and environmental factors on the Central Nervous System. Depression that may occur in MS patients leads to decreased motivation and negatively affects the quality of life. At the same time, depression may be accompanied by sleep disorders, anxiety, fatigue and eating disorders. Nutrition is recognised as one of the possible risk factors for the development of MS and has potential applications in the management and treatment of the disease. When the literature was reviewed, there is no study evaluating the effect of intermittent fasting and Mediterranean diet on quality of life, sleep, circadian rhythm and appetite hormones leptin and ghrelin levels in MS patients and comparing the two diet types in terms of all these parameters.

Conditions

Multiple Sclerosis; Intermittent Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. Group (intermittent fasting)

Time Restricted Diet (10.00-18.00)

Group Type: EXPERIMENTAL

application of different types of diet

Intervention Type: OTHER

application of different types of diet

2. Group (mediterranean diet)

Diet based on the consumption of plant foods, cereals, oilseeds, etc.

Group Type: EXPERIMENTAL

application of different types of diet

Intervention Type: OTHER

application of different types of diet

Interventions

application of different types of diet

application of different types of diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To apply to the neurology outpatient clinic, to be a female between the ages of 18-65 who has been diagnosed with MS by a physician
• Not being in the attack period
• Not being in menopause Not being diagnosed with any autoimmune system disease other than -MS that may adversely affect the study,
• Not following the Mediterranean diet and intermittent fasting programmes in the last three months,
• Not being diagnosed with an eating behaviour disorder,
• Not having any communication problems,
• Signing the informed consent form,
• Brain MRI within the last three months,
• Not to be pregnant and lactating
• No physical disability No history of cancer
• Body Mass Index between 18,5 kg/m2- 29,9 kg/m2,
• Not losing 5% and/or more body weight in the last month

Exclusion Criteria

• Having a diagnosis of autoimmune system disease that may adversely affect working outside of -MS,
• To be in the attack period-Being under 18 years of age and over 65 years of age
• Being in menopause-Mediterranean diet and intermittent fasting feeding programmes within the last three months,
• Diet therapy that has an effect on the autoimmune system within the last three months,
• Being diagnosed with eating behaviour disorder,
• Having any communication problems,- Not signing the informed consent form,
• Failure to adapt to the work during the working period, to be in a situation/behaviour that may adversely affect the work,
• To have applied any nutritional intervention during the last three months prior to the study,
• Taking supplements such as selenium, zinc, iron, vitamin D and/or B12, which may affect the course of the study,
• To have received cancer treatment and / or to be receiving cancer treatment,
• Other neurological diseases (e.g. Parkinson's, epilepsy, Alzheimer's),
• Diagnosed with a disease lasting more than 4 months in the last 12 months and other specialised dietary / compositionally different dietary patterns (e.g. high protein, ketogenic, low energy content < 1000 kcal/day),
• Body Mass Index <18.5 kg/m2 or >30 kg/m2
• Losing 5% and/or more body weight in the last month,
• Having a physical disability

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Acibadem University

OTHER

Sponsor Role: collaborator

Nigde Omer Halisdemir University

OTHER

Sponsor Role: lead

Responsible Party

Elif Gökçe İNBAŞI

Lecturer, MSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nihan Çakır Biçer, PhD.

Role: STUDY_DIRECTOR

Acıbadem Mehmet Ali Aydınlar University

Locations

Nigde Omer Halisdemir University

Niğde, Bor, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Elif Gökçe İnbaşı, MSc.

Role: CONTACT

einbasi@ohu.edu.tr

0388 311 86 00 ext. 2098

Nihan Çakır Biçer, PhD.

Role: CONTACT

nihan.bicer@acibadem.edu.tr

Facility Contacts

Elif Gökçe İnbaşı, MSc.

Role: primary

einbasi@ohu.edu.tr

0388 311 86 00 ext. 2098

Nihan Çakır Biçer, PhD.

Role: backup

nihan.bicer@acibadem.edu.tr

Other Identifiers

2024-7/286

Identifier Type: -

Identifier Source: org_study_id