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

NCT05175378 | Completed

• 1 other identifier: #E31052019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

relapsing-remitting multiple sclerosis; Mediterranean diet; cardiovascular health

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

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

Control arm

SHAM COMPARATOR

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

Interventions

Lifestyle intervention OTHER

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.

Control arm; Intervention arm

Eligibility Criteria

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

Sponsors & Collaborators

• Iaso Maternity Hospital, Athens, Greece: lead
• Harokopio University: collaborator
• G.Gennimatas General Hospital: collaborator

Study Sites (1)

Iaso Hospital

Athens, Greece

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: * All patients were randomly assigned to either the control or the intervention group, using single randomization. An independent researcher applied a computerized sequence to generate the randomization list. Next, the principal investigator who was responsible for the completion of each participant's form recorded the patient trial number in a sealed envelope. Maintenance of the blind-to-treatment allocation was performed in order to avoid bias. Treatment data were exposed to the analyst only after assessing outcomes. During the 3-month intervention, dietitians performed regular phone interviews on a 15-day basis to assist nutritional and lifestyle consultation in both groups. * All patients were instructed to keep (a) weekly food diaries (2 weekdays and 1 weekend day) and (b) 24-hour dietary records, which all were assessed remotely via emails and unexpected phone calls.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Randomized, case control study

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: December 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 12, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)