Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis

NCT06546033 | Recruiting

• 1 other identifier: 2024-7/286
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Intermittent Fasting

Keywords

Multiple sclerosis; circadian rhythm; mediterranean diet; Intermittent Fasting

Outcome Measures

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.

  baseline- 3 months

Secondary Outcomes (3)

• The Morning and Evening Questionnaire

  baseline- 3 months

• Pittsburgh Sleep Quality Index

  baseline- 3 months

• Multiple Sclerosis Quality of Life-MuSiQoL

  baseline- 3 months

Study Arms (2)

1. Group (intermittent fasting)

EXPERIMENTAL

Time Restricted Diet (10.00-18.00)

Other: application of different types of diet

2. Group (mediterranean diet)

EXPERIMENTAL

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

Other: application of different types of diet

Interventions

application of different types of diet OTHER

application of different types of diet

1. Group (intermittent fasting); 2. Group (mediterranean diet)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead
• Acibadem University: collaborator

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Bor, 51200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Intermittent Fasting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Nihan Çakır Biçer, PhD.

  Acıbadem Mehmet Ali Aydınlar University

  STUDY DIRECTOR

Central Study Contacts

Elif Gökçe İnbaşı, MSc.

CONTACT

0388 311 86 00; einbasi@ohu.edu.tr

Nihan Çakır Biçer, PhD.

CONTACT

nihan.bicer@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, MSc.

Model Details: The first group will be fed with Mediterranean diet The second group will be fed with intermittent diet

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)