Clinical trial NCT06546033: Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis
Official title: Determination of the Effects of Intermittent Fasting and Mediterranean Diet on Quality of Life, Circadian Rhythm and Appetite Markers in Patient With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Intermittent Fasting
Keywords: Multiple sclerosis
circadian rhythm
mediterranean diet
Intermittent Fasting
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Acibadem University
First posted: 2024-08-09
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The first group will be fed with Mediterranean diet The second group will be fed with intermittent diet
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Biochemical parameter
timeFrame: baseline- 3 months
Secondary outcomes:
measure: The Morning and Evening Questionnaire
timeFrame: baseline- 3 months
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline- 3 months
measure: Multiple Sclerosis Quality of Life-MuSiQoL
timeFrame: baseline- 3 months
Other outcomes:
Locations:
city: Nigde
country: Turkey
facility: Nigde Omer Halisdemir University
state: Bor
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Nihan Çakır Biçer, PhD.
role: STUDY_DIRECTOR
References: