Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis

August 5, 2024 updated by: Elif Gökçe İNBAŞI, Nigde Omer Halisdemir University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elif Gökçe İnbaşı, MSc.
  • Phone Number: 2098 0388 311 86 00
  • Email: einbasi@ohu.edu.tr

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1. Group (intermittent fasting)
Time Restricted Diet (10.00-18.00)
Other: application of different types of diet
application of different types of diet
Experimental: 2. Group (mediterranean diet)
Diet based on the consumption of plant foods, cereals, oilseeds, etc.
Other: application of different types of diet
application of different types of diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline- 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Morning and Evening Questionnaire
Time Frame: baseline- 3 months
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.
baseline- 3 months
Pittsburgh Sleep Quality Index
Time Frame: baseline- 3 months
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.
baseline- 3 months
Multiple Sclerosis Quality of Life-MuSiQoL
Time Frame: baseline- 3 months
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.
baseline- 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nigde Omer Halisdemir University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Acibadem University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nihan Çakır Biçer, PhD., Acıbadem Mehmet Ali Aydınlar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-7/286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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