Multiple SclerosisNCT06546033
Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis
A study testing application of different types of diet in people with Multiple Sclerosis and Intermittent Fasting, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Multiple Sclerosis, Intermittent Fasting
- What is being tested?
- application of different types of diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2024to 2 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- 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,
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nihan Çakır Biçer, PhD. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nigde Omer Halisdemir University
Niğde, Bor, 51200
Elif Gökçe İnbaşı, MSc., 0388 311 86 00 ext. 2098, einbasi@ohu.edu.tr
Nihan Çakır Biçer, PhD., nihan.bicer@acibadem.edu.tr
About this study
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
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.
Read the 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
- Being tested
- application of different types of diet
- Keywords
- Multiple sclerosis, circadian rhythm, mediterranean diet, Intermittent Fasting
- Medical subject headings
- Multiple Sclerosis, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of different types of dietOther
application of different types of diet
| Study group | Role | What they receive |
|---|---|---|
| 1. Group (intermittent fasting) | Experimental | Time Restricted Diet (10.00-18.00) Receives: Other: application of different types of diet |
| 2. Group (mediterranean diet) | Experimental | Diet based on the consumption of plant foods, cereals, oilseeds, etc. Receives: Other: application of different types of diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameter
Hemogram values of the group 1 and group 2 patients with multiple sclerosis participating in the study will be compare.
Measured: baseline- 3 months
Secondary outcomes (3)
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.
Measured: baseline- 3 months
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.
Measured: baseline- 3 months
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.
Measured: baseline- 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start2 May 2024
- Primary completion2 Sep 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group will be fed with Mediterranean diet The second group will be fed with intermittent diet
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- Acibadem University
- Responsible party
- Principal investigator, Elif Gökçe İNBAŞI, Nigde Omer Halisdemir University
- Investigators
- Nihan Çakır Biçer, PhD., Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546033
- Sponsor's protocol ID
- 2024-7/286
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06546033
- Acronym / sponsor ID
- 2024-7/286
- Conditions
- Multiple Sclerosis, Intermittent Fasting
- Keywords
- Multiple sclerosis, circadian rhythm, mediterranean diet, Intermittent Fasting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- Acibadem University
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group will be fed with Mediterranean diet The second group will be fed with intermittent diet
| Arm | Type | Receives |
|---|---|---|
| 1. Group (intermittent fasting) | Experimental | Other: application of different types of dietTime Restricted Diet (10.00-18.00) |
| 2. Group (mediterranean diet) | Experimental | Other: application of different types of dietDiet based on the consumption of plant foods, cereals, oilseeds, etc. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of different types of dietapplication of different types of diet | Other | 1. Group (intermittent fasting), 2. Group (mediterranean diet) |
Primary outcome
Biochemical parameter
Time frame: baseline- 3 months
Hemogram values of the group 1 and group 2 patients with multiple sclerosis participating in the study will be compare.
3 secondary outcomes
The Morning and Evening Questionnaire
Time frame: baseline- 3 months
Pittsburgh Sleep Quality Index
Time frame: baseline- 3 months
Multiple Sclerosis Quality of Life-MuSiQoL
Time frame: baseline- 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nihan Çakır Biçer, PhD. contact
Nihan Çakır Biçer, PhD. study director
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of different types of diet in people with Multiple Sclerosis and Intermittent Fasting, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Gökçe İnbaşı, MSc. (0388 311 86 00 ext. 2098, einbasi@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical parameter (time frame: baseline- 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.