Lupus Erythematosus, SystemicNCT05379725
Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus
A study testing Mediterranean Dietary Pattern and High Fermented Food Dietary Pattern in people with Lupus Erythematosus, Systemic, run by University of Florida at 1 site in United States.
Trial summary
This is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Mediterranean Dietary Pattern and High Fermented Food Dietary Pattern
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Able to provide informed consent and undertake study questionnaire completion in English
- Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care
- Be willing and able to comply with all the study-related procedures
Who cannot join
- Pregnant or planning pregnancy within the duration of the interventional study.
- Currently following a vegetarian/vegan diet.
- Allergy/sensitivity to gluten, soy, or cow's milk.
- Self-disclosure of lactose intolerance
- Inability to comply with the study procedures.
- Baseline dietary fiber intake > 30 g/day
- MEDAS score at baseline > 9
- Baseline consumption of > 2 servings per day of fermented foods
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida/UF Health
Gainesville, Florida, 32611
About this study
Official title: Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation and Disease Activity in Systemic Lupus Erythematosus
This is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE).
Read the detailed description
Given the demonstrated beneficial effects of the Mediterranean dietary pattern in autoimmune disease and the potential benefit of a high-fermented-food diet on inflammatory profiles, we aim to determine the feasibility and relative benefit of a Mediterranean dietary pattern versus a high-fermented-food diet on inflammatory markers and clinical outcomes in individuals with SLE. The primary aim of the study is to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with SLE. Secondary aims will determine the effects of the Mediterranean dietary pattern and a high-fermented-food diet on attenuating inflammation and disease activity in individuals with SLE. This is a 4-month randomized controlled trial with a 1-month baseline of usual diet and 3-month intervention. Participants will complete the online DHQ III and diet adherence questionnaires monthly. Blood will be obtained at randomization and at the end of the intervention period for analysis of inflammatory cytokines. Dietary intake during baseline and intervention will be assessed by 5, ASA 24-h dietary recalls.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Mediterranean Dietary Pattern, High Fermented Food Dietary Pattern
- Keywords
- SLE, Lupus, Mediterranean diet, Fermented food, Inflammation
- Medical subject headings
- Lupus Erythematosus, Systemic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Dietary PatternOther
The Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil.
High Fermented Food Dietary PatternOther
Fermented foods such as yogurt, kefir, fermented cottage cheese, fermented vegetables, vegetable brine drinks, kombucha, other fermented non-alcoholic drinks, and other foods will be recommended.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Experimental | Participants will receive diet education on adherence to a Mediterranean dietary pattern. Receives: Other: Mediterranean Dietary Pattern |
| Fermented food | Experimental | Participants will receive diet education on adherence to a high fermented food dietary pattern. Receives: Other: High Fermented Food Dietary Pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence - Mediterranean Diet
Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score
Measured: baseline, month 1, 2 and 3
Adherence - Fermented Food Diet
Percent of participants achieving > 5 servings of fermented foods per day
Measured: baseline, month 1, 2, and 3
Secondary outcomes (6)
Diet Quality
Healthy Eating Index 2015 score (0 minimum to 100 maximum). Higher values indicate better diet quality.
Measured: baseline, month 3
Systemic Lupus Erythematosus Disease Activity
Systemic Lupus Erythematosus disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (0 minimum and 105 maximum, with higher scores representing higher disease activity.
Measured: baseline, month 3
ESR
Erythrocyte sedimentation rate
Measured: baseline, month 3
hsCRP
high-sensitivity C-reactive protein
Measured: baseline, month 3
anti-dsDNA
Anti-double stranded DNA
Measured: baseline, month 3
Cytokine profile
Cytokines profile e.g., interleukin-18 (IL-18), tumor necrosis factor (TNF), IL-6, IL-2, IL-10
Measured: baseline, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start22 Mar 2022
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Why it stopped: Lack of funding to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379725
- Sponsor's protocol ID
- IRB202200703
- Status last verified
- Jun 2025
- First submitted
- 9 May 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation and Disease Activity in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05379725
- Acronym / sponsor ID
- IRB202200703
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- SLE, Lupus, Mediterranean diet, Fermented food, Inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding to continue.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 May 2022 (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 is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE).
Detailed description
Given the demonstrated beneficial effects of the Mediterranean dietary pattern in autoimmune disease and the potential benefit of a high-fermented-food diet on inflammatory profiles, we aim to determine the feasibility and relative benefit of a Mediterranean dietary pattern versus a high-fermented-food diet on inflammatory markers and clinical outcomes in individuals with SLE. The primary aim of the study is to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with SLE. Secondary aims will determine the effects of the Mediterranean dietary pattern and a high-fermented-food diet on attenuating inflammation and disease activity in individuals with SLE. This is a 4-month randomized controlled trial with a 1-month baseline of usual diet and 3-month intervention. Participants will complete the online DHQ III and diet adherence questionnaires monthly. Blood will be obtained at randomization and at the end of the intervention period for analysis of inflammatory cytokines. Dietary intake during baseline and intervention will be assessed by 5, ASA 24-h dietary recalls.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Experimental | Other: Mediterranean Dietary PatternParticipants will receive diet education on adherence to a Mediterranean dietary pattern. |
| Fermented food | Experimental | Other: High Fermented Food Dietary PatternParticipants will receive diet education on adherence to a high fermented food dietary pattern. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years of age
- Able to provide informed consent and undertake study questionnaire completion in English
- Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care
- Be willing and able to comply with all the study-related procedures
Key exclusion criteria (8 listed)
- Pregnant or planning pregnancy within the duration of the interventional study.
- Currently following a vegetarian/vegan diet.
- Allergy/sensitivity to gluten, soy, or cow's milk.
- Self-disclosure of lactose intolerance
- Inability to comply with the study procedures.
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 |
|---|---|---|
| Mediterranean Dietary PatternThe Mediterranean dietary pattern includes whole or minimally processed foods with a high intake of vegetables, fruits, whole grains, fish, and olive oil. | Other | Mediterranean diet |
| High Fermented Food Dietary PatternFermented foods such as yogurt, kefir, fermented cottage cheese, fermented vegetables, vegetable brine drinks, kombucha, other fermented non-alcoholic drinks, and other foods will be recommended. | Other | Fermented food |
Primary outcome
Adherence - Mediterranean Diet
Time frame: baseline, month 1, 2 and 3
Percent of participants achieving 'good to very good adherence') as assessed by the 14-day Mediterranean diet questionnaire (MEDAS) score
Adherence - Fermented Food Diet
Time frame: baseline, month 1, 2, and 3
Percent of participants achieving > 5 servings of fermented foods per day
6 secondary outcomes
Diet Quality
Time frame: baseline, month 3
Systemic Lupus Erythematosus Disease Activity
Time frame: baseline, month 3
ESR
Time frame: baseline, month 3
hsCRP
Time frame: baseline, month 3
anti-dsDNA
Time frame: baseline, month 3
Cytokine profile
Time frame: baseline, month 3
Results and safety
The study was stopped early (reason given: Lack of funding to continue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Dietary Pattern and High Fermented Food Dietary Pattern in people with Lupus Erythematosus, Systemic, run by University of Florida at 1 site in United States.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 26 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 United States. 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?
The study was stopped early (reason given: Lack of funding to continue.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence - Mediterranean Diet (time frame: baseline, month 1, 2 and 3). The study lists 2 primary outcomes in all. 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 26 Jun 2025.