Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNigde Omer Halisdemir University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
application of different types of diet
Other interventionapplication of different types of diet
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: 1. Group (intermittent fasting)Experimental treatment 1 intervention
Group B: 2. Group (mediterranean diet)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Biochemical parameter
Hemogram values of the group 1 and group 2 patients with multiple sclerosis participating in the study will be compare.
Time frame
baseline- 3 monthsSecondary outcomes
1
The Morning and Evening Questionnaire
The Morning and Evening Questionnaire was developed by Horne and Ostberg in 1975. The Turkish validity and reliability scale has 19 questions and is unidimensional. It is a 5-point Likert type (1=absolutely morning person-5=absolutely evening person) and the score that can be obtained from the scale varies between 0 and 86. Each score to be taken from the scale remains in different score ranges. This represents a different personality trait.
Time frame
baseline- 3 months2
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI) was developed by Buysse et al. The scale, which was developed by Buysse et al. and its Turkish validity and reliability was performed, consists of 18 self-report questions and measures the sleep quality of the individual in the last 4 weeks. PDQI has 7 components. Each of these components is scored between 0-3. A minimum score of 0 and a maximum score of 21 is obtained from the scale. A total score of 5 and above indicates poor sleep quality.
Time frame
baseline- 3 months3
Multiple Sclerosis Quality of Life-MuSiQoL
Multiple Sclerosis Quality of Life-MuSiQoL scale was developed by Vickrey et al. in 1995 to evaluate the quality of life of MS patients. The original version consists of 74 questions and there is also a short form consisting of 31 questions. MuSiQoL consists of a total of 9 subgroups including activities of daily living, psychological status, findings, friendships, family relationships, emotional and sexual life, acceptance, coping with the disease and satisfaction with health services. During the assessments, individuals are asked to answer by taking into account their situation in the last 4 weeks. They are asked to tick the option that best expresses themselves from the options of never (0: Never), rarely (1: Occasionally), sometimes (2: Some), frequently (3: Very) and always (4: Very much). Turkish validity and reliability studies were conducted.
Time frame
baseline- 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nigde Omer Halisdemir University
Lead sponsor
Acibadem University
Collaborator
Source ClinicalTrials.gov