NCT07033975

Brief Summary

This study examines the impact of a Mediterranean diet on individuals with multiple sclerosis (MS). MS is a multifactorial disease in which environmental factors, such as nutrition, can influence disease progression. Therefore, this study aims to investigate whether a healthier dietary pattern, specifically a flavonoid-rich Mediterranean diet, can affect disease parameters.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
31mo left

Started Apr 2023

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2023Dec 2028

Study Start

First participant enrolled

April 4, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 24, 2025

Status Verified

April 1, 2025

Enrollment Period

5.7 years

First QC Date

April 24, 2025

Last Update Submit

June 23, 2025

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Microbiota changes

    Microbiota sequencing on fecal samples to identify the different bacterial strains that are present.

    Three timepoints, before start of the strict diet (day 14), after the strict diet (day 31), and after the follow-up period of three months (day 122).

Study Arms (1)

Flavonoid-enriched Mediterranean Diet

EXPERIMENTAL
Other: Flavonoid-enriched Mediterranean Diet

Interventions

Flavonoid-enriched Mediterranean DietOTHER

A set of dietary guidelines describing an adjusted Mediterranean diet focusing on the intake of flavonoid-rich products.

Flavonoid-enriched Mediterranean Diet

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Expanded Disability Status Scale (EDSS): 0-6

You may not qualify if:

  • Diagnosed digestive pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jerome JA Hendriks, Professor

CONTACT

+3211269207jerome.hendriks@uhasselt.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Jerome J.A. Hendriks

Study Record Dates

First Submitted

April 24, 2025

First Posted

June 24, 2025

Study Start

April 4, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 24, 2025

Record last verified: 2025-04

Locations

BE(1)