Multiple SclerosisFLAMEMSNCT07033975
A Specialized Diet for Multiple Sclerosis
A study testing Flavonoid-enriched Mediterranean Diet in people with Multiple Sclerosis, run by Jerome J. A. Hendriks at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Flavonoid-enriched Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Apr 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expanded Disability Status Scale (EDSS): 0-6
Who cannot join
- Diagnosed digestive pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Diepenbeek, Limburg, 3590
Jerome JA Hendriks, Professor, +3211269207, jerome.hendriks@uhasselt.be
About this study
Official title: A Flavonoid-enriched Mediterranean Diet for Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Flavonoid-enriched Mediterranean Diet
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavonoid-enriched Mediterranean DietOther
A set of dietary guidelines describing an adjusted Mediterranean diet focusing on the intake of flavonoid-rich products.
| Study group | Role | What they receive |
|---|---|---|
| Flavonoid-enriched Mediterranean Diet | Experimental | Not described Receives: Other: Flavonoid-enriched Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota changes
Microbiota sequencing on fecal samples to identify the different bacterial strains that are present.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start4 Apr 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jerome J. A. Hendriks
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt
- Responsible party
- Sponsor-investigator, Jerome J. A. Hendriks, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033975
- Sponsor's protocol ID
- B1152023000003
- Acronym
- FLAMEMS
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Flavonoid-enriched Mediterranean Diet for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07033975
- Acronym / sponsor ID
- FLAMEMS / B1152023000003
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jerome J. A. HendriksUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flavonoid-enriched Mediterranean Diet | Experimental | Other: Flavonoid-enriched Mediterranean Diet |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Expanded Disability Status Scale (EDSS): 0-6
Key exclusion criteria (1 listed)
- Diagnosed digestive pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flavonoid-enriched Mediterranean DietA set of dietary guidelines describing an adjusted Mediterranean diet focusing on the intake of flavonoid-rich products. | Other | Flavonoid-enriched Mediterranean Diet |
Primary outcome
Microbiota changes
Time frame: 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).
Microbiota sequencing on fecal samples to identify the different bacterial strains that are present.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flavonoid-enriched Mediterranean Diet in people with Multiple Sclerosis, run by Jerome J. A. Hendriks at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerome JA Hendriks, Professor (+3211269207, jerome.hendriks@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota changes (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.