Adherence to Mediterranean Diet and Cardiovascular Health in Multiple Sclerosis Female Patients: a Case Control Study

Multiple sclerosis (MS) is a chronic immune-mediated neurodegenerative disease that affects the central nervous system (CNS). The exact pathophysiology of MS remains unclear; it is suggested that the inflammatory state persists under a genetic-energetic-environmental complex causing a variety of clinical symptoms depending on the neuroanatomical location of MS lesions. The age of MS onset ranges between 20 and 40 years. MS is usually initiated as a relapsing-remitting disease, which may last several years to decades affecting females twice as often as males. Dietary factors may have an important impact on MS. Data from human and animal studies indicate that saturated fatty acids (SFA), the major fat type of animal foods in the "Western" diet, increase MS susceptibility. The Mediterranean dietary (MedDiet) pattern is hypothesized to be beneficial to MS patients protecting against the development cardiovascular diseases. However, little is known about the cardiovascular effects of the MedDiet on MS patients. Consequently, the aim of the present randomized, case control study was to investigate the effects of MedDiet on cardiovascular factors in women with relapsing-remitting MS after a 3-month intervention period.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Lifestyle intervention

Detailed Description

• Adult women with MS, who were outpatients of Iaso Hospital (Athens, Greece), were enrolled in the present study. Detailed information was provided using a leaflet, in which aims and methodology were described before recruitment. All participants fulfilled informed consent and kept a signed copy. Before the start of the trial, the Ethics Committee of Iaso Hospital (Athens, Greece) assessed and approved the protocol of the study (Approval Code #E31052019). The study was performed according to principles of the Helsinki Declaration (1964) and terms of Good Clinical Practice.
• The study took place during the winter season. All patients were recruited at the first week of December 2020 and the intervention lasted 3 months.
• Study design: 3-month randomized, single center case control study; maintenance of the blind-to-treatment allocation was performed in order to avoid bias; in the intervention group, MS women received a personalized daily eating plan generated by a Clinical Decision Support System (CDSS) together with nutritional consultation on the Meditteranean dietary pattern, as well as physical activity guidelines; patients of the control group received general dietary advice and physical activity recommendation that was in accordance with the "National Dietary Guidelines for Greek adults";
• Screening: medical history; nutritional history (food frequency questionnaire, MedDietScore, 24-hr recalls); anthropometrics; depression and anxiety (Hospital Anxiety and Depression Scale); blood biomarkers (glucose, lipids, C-reactive protein).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Iaso Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: adult women (≥ 18 years) with relapsing-remitting MS diagnosis; patients should follow a standardized immunomodulatory therapy or other disease-modifying therapy for at least 6 months; the patient should be able to walk without aid or work a full day in a position of average difficulty, as indicated by scores of Expanded Disability Status Scale (EDSS) < 4.5; patients with at least one lesion on brain MRI and/or at least one relapse in the past two years.

Exclusion Criteria: women with concomitant illness (e.g. malignancy, infections, malabsorption, heart-, liver- or renal failure); patients who changed treatment during or ≤ 6 months before the start or the trial; psychiatric conditions, alcoholism, drug addiction; using vitamin or mineral supplements during or ≤ 6 months prior to screening; following a vegan diet ≤ 5 years prior to screening or using weight loss medications; pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention arm; In the intervention group, MS women received a personalized daily eating plan (specific meals, recipes, food portions) together with nutritional consultation on the Meditteranean dietary pattern, as well as physical activity guidelines. All essential aspects of the dietary plan e.g. daily energy expenditure, classification of physical activity based on the concept of metabolic equivalent (MET), caloric adjustment according to nutritional status, and macronutrient distribution were calculated by a Clinical Decision Support System (CDSS). Body mass index (BMI) was also calculated, as the ratio of reported weight (kg) to the square of height (m2). Co-existed health issues, such as constipation or esophageal reflux, were taken into consideration. All MS patients acquired personal login passwords that allowed them to get access to their personal CDSS account and track their progress in regards to body weight, physical activity, and healthy food choices consumption.	Other: Lifestyle intervention; We investigated the potential cardiovascular health effects of the Mediterranean dietary pattern on adult women with relapsing-remitting multiple sclerosis, in regards to body weight, body composition, cardiovascular blood biomarkers (fasting glucose, lipids, C-reactive protein), as well as depression and anxiety levels.
Sham Comparator: Control arm; Patients of the control group received general dietary advice and physical activity recommendation that was in accordance with the "National Dietary Guidelines for Greek adults"	Other: Lifestyle intervention; We investigated the potential cardiovascular health effects of the Mediterranean dietary pattern on adult women with relapsing-remitting multiple sclerosis, in regards to body weight, body composition, cardiovascular blood biomarkers (fasting glucose, lipids, C-reactive protein), as well as depression and anxiety levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MedDietScore	The MedDietScore questionnaire estimated the degree of adherence to MD at the start of the study and at 3 months. Scoring ranges from "0" to "55" and higher scores signify greater MD adherence.	3 months

Collaborators and Investigators

• Sponsor: Iaso Maternity Hospital, Athens, Greece
• Collaborators: Harokopio University; G.Gennimatas General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Mediterranean diet; cardiovascular health; relapsing-remitting multiple sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: #E31052019

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