Hidradenitis SuppurativaHSMDSNCT07800416
Mediterranean Dietary Intervention for HS
A study testing Mediterranean Diet Counseling and Mediterranean Food Support in people with Hidradenitis Suppurativa, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether a 16-week Mediterranean-style dietary counseling program, called the Med-South Lifestyle Program (MSLP), is practical and acceptable for adults with hidradenitis suppurativa (HS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Mediterranean Diet Counseling and Mediterranean Food Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of hidradenitis suppurativa confirmed by a board-certified dermatologist
- Hurley stage I, II, or III
- Baseline abscess and inflammatory nodule (AN) count of at least 3, so that disease activity is measurable in every enrolled participant
- Reliable access to Zoom by laptop, tablet, or smartphone
- Able to provide written informed consent in English
Who cannot join
- Systemic antibiotic use (oral, intramuscular, or intravenous) within 28 days before the planned enrollment visit
- Topical antibiotic use within 5 days before the planned enrollment visit
- Background HS therapy that has not been stable for the 28 days before enrollment, or that is not expected to remain stable through the 16-week study period
- Currently pregnant or breastfeeding
- Unable to complete study procedures in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill, Department of Dermatology
Chapel Hill, North Carolina, 27599
Ray Cheever, BS, christopher_cheever@med.unc.edu
About this study
Official title: Pilot Feasibility Study of a Mediterranean Diet Intervention for Hidradenitis Suppurativa
The goal of this clinical trial is to learn whether a 16-week Mediterranean-style dietary counseling program, called the Med-South Lifestyle Program (MSLP), is practical and acceptable for adults with hidradenitis suppurativa (HS). The study will also look at whether participants' Mediterranean diet adherence changes during the program.
The main questions it aims to answer are:
Read more
- Do participants find the program feasible and practical to follow?
- Does adherence to a Mediterranean-style diet change from the beginning to the end of the 16-week program?
- Do participants find the program acceptable? All participants will receive the same program; there is no comparison group.
Participants will:
- Take part in individual nutrition counseling and shorter support calls, mostly by video or telephone
- Complete a cooking education session and receive written nutrition materials
- Receive Mediterranean-style food support, including pantry staples and prepared meals
- Attend two in-person study visits, at the beginning and end of the 16-week program
- Complete questionnaires and study assessments and provide biological samples Because this is a pilot study, the information collected will primarily be used to improve the program and help plan a larger future clinical trial.
Read the detailed description
This study involves a 16-week Mediterranean-style eating program for people with hidradenitis suppurativa (HS). The program is called the Med-South Lifestyle Program (MSLP) and is designed to support practical, realistic dietary changes.
Most study activities are completed remotely. Participants will have two in-person visits, at the beginning and end of the study, usually scheduled after a regular dermatology appointment to avoid an extra clinic trip.
Participants will receive one-on-one nutrition counseling by video call from dietetic students supervised by a registered dietitian. Counseling sessions occur throughout the 16 weeks and include nutrition education, goal setting, and practical strategies for following a Mediterranean-style diet. Participants will also complete a cooking education session and receive written program materials.
Participants will receive some food support, including Mediterranean pantry staples such as olive oil, herbs, and spices, as well as prepared meals delivered during the study. Food allergies, intolerances, and dietary restrictions will be reviewed before food is provided.
Participants will complete brief questionnaires during the study and additional study activities at the beginning and end. These visits may include health measurements and collection of blood, urine, saliva, stool, and skin swab samples.
At the end of the study, participants will also have an opportunity to provide feedback about their experience with the program.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Mediterranean Diet Counseling, Mediterranean Food Support
- Keywords
- Mediterranean diet, Feasibility study, Dietary counseling, Pilot study
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet CounselingBehavioural
Also called MSLP
Participants receive a 16-week Mediterranean-pattern dietary counseling program delivered primarily by video call. Individual counseling is provided by dietetic students under the supervision of a registered dietitian. Six core sessions occur at Weeks 1, 2, 5, 8, 11, and 14, with five individualized adherence-support contacts at Weeks 3, 6, 9, 12, and 15. Core sessions cover vegetables and fruit; whole grains and legumes; nuts, oils, dressings, and spreads; beverages, desserts, and snacks; eating out and sodium; and fish, meat, poultry, dairy, and eggs. Sessions include progress review, nutrition education, collaborative goal setting, an action plan, and planning for the next contact. A group or recorded cooking education module is completed between Weeks 5 and 8. Printed materials include HS and nutrition summaries, the MSLP manual, and cookbook.
Mediterranean Food SupportOther
Participants receive Mediterranean-pattern food support during the 16-week intervention to facilitate implementation of the dietary recommendations. At the baseline study visit, participants receive selected Mediterranean pantry staples, including extra-virgin olive oil, herbs, and spices. Home-delivered prepared meals consistent with the intervention dietary pattern are also provided during the study period.
Before food is provided, participants complete an allergy and food-intolerance screening. Dietary restrictions and preferences relevant to food provision are reviewed before subsequent deliveries. Receipt of pantry items and meal deliveries is documented, and participants are asked to report the amount of each delivered meal consumed.
| Study group | Role | What they receive |
|---|---|---|
| Med-South Lifestyle Program (MSLP) | Experimental | Participants receive a 16-week Mediterranean-pattern dietary intervention consisting of individualized dietary counseling, a cooking education module, Mediterranean food support, and printed educational materials. Participants complete in-person study visits at baseline (Week 0) and Week 16, scheduled in conjunction with routine dermatology appointments when possible. Receives: Behavioral: Mediterranean Diet Counseling; Other: Mediterranean Food Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure (FIM) is a four-item participant-reported measure of the perceived feasibility of the intervention. Each item is rated on a five-point Likert scale from 1 (completely disagree) to 5 (completely agree), and the four item scores are averaged to give a total score ranging from 1 to 5. Higher scores indicate greater perceived feasibility. Scores will be summarized among participants with available Week 16 responses.The number of participants contributing data will be reported, and missing Week 16 assessments will be reported as missing rather than treated as study exclusions.
Measured: Week 16
Secondary outcomes (2)
Change in Mediterranean Diet Adherence Screener (MEDAS) Score
The Mediterranean Diet Adherence Screener (MEDAS) is a validated 14-item screener developed in the PREDIMED study. Twelve items address the frequency of consumption of specified foods and two address food consumption habits. Each item scores 1 when the Mediterranean-pattern criterion is met and 0 when it is not, resulting in a total score ranging from 0 to 14, with higher scores indicating greater adherence to the Mediterranean dietary pattern. The alcohol item is scored according to the original PREDIMED criterion; increasing alcohol intake is not a goal of the intervention, and a prespecified sensitivity analysis will repeat this outcome using the 13-item score with the alcohol item omitted. The outcome is calculated as the Week 16 MEDAS total score minus the Week 0 MEDAS total score and can range from -14 to +14; positive values indicate increased adherence, negative values indicate decreased adherence, and 0 indicates no change.
Measured: Week 0 and Week 16
Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) is a four-item participant-reported measure of the acceptability of the intervention. Each item is rated on a five-point Likert scale from 1 (completely disagree) to 5 (completely agree), and the four item scores are averaged to give a total score ranging from 1 to 5. Higher scores indicate greater acceptability. Scores will be summarized among participants with available Week 16 responses. The number of participants contributing data will be reported, and missing Week 16 assessments will be reported as missing rather than treated as study exclusions.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Hidradenitis Suppurativa Foundation
- Responsible party
- Sponsor
- Investigators
- Christopher J Sayed, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800416
- Sponsor's protocol ID
- 26-0451
- Acronym
- HSMDS
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results reported in this study will be shared beginning 9 months following article publication and continuing for 36 months, provided that the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of a Mediterranean Diet Intervention for Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07800416
- Acronym / sponsor ID
- HSMDS / 26-0451
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Mediterranean diet, Feasibility study, Dietary counseling, Pilot study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Hidradenitis Suppurativa Foundation
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
The goal of this clinical trial is to learn whether a 16-week Mediterranean-style dietary counseling program, called the Med-South Lifestyle Program (MSLP), is practical and acceptable for adults with hidradenitis suppurativa (HS). The study will also look at whether participants' Mediterranean diet adherence changes during the program.
The main questions it aims to answer are:
- Do participants find the program feasible and practical to follow?
- Does adherence to a Mediterranean-style diet change from the beginning to the end of the 16-week program?
- Do participants find the program acceptable? All participants will receive the same program; there is no comparison group.
Participants will:
- Take part in individual nutrition counseling and shorter support calls, mostly by video or telephone
- Complete a cooking education session and receive written nutrition materials
- Receive Mediterranean-style food support, including pantry staples and prepared meals
- Attend two in-person study visits, at the beginning and end of the 16-week program
- Complete questionnaires and study assessments and provide biological samples Because this is a pilot study, the information collected will primarily be used to improve the program and help plan a larger future clinical trial.
Detailed description
This study involves a 16-week Mediterranean-style eating program for people with hidradenitis suppurativa (HS). The program is called the Med-South Lifestyle Program (MSLP) and is designed to support practical, realistic dietary changes.
Most study activities are completed remotely. Participants will have two in-person visits, at the beginning and end of the study, usually scheduled after a regular dermatology appointment to avoid an extra clinic trip.
Participants will receive one-on-one nutrition counseling by video call from dietetic students supervised by a registered dietitian. Counseling sessions occur throughout the 16 weeks and include nutrition education, goal setting, and practical strategies for following a Mediterranean-style diet. Participants will also complete a cooking education session and receive written program materials.
Participants will receive some food support, including Mediterranean pantry staples such as olive oil, herbs, and spices, as well as prepared meals delivered during the study. Food allergies, intolerances, and dietary restrictions will be reviewed before food is provided.
Participants will complete brief questionnaires during the study and additional study activities at the beginning and end. These visits may include health measurements and collection of blood, urine, saliva, stool, and skin swab samples.
At the end of the study, participants will also have an opportunity to provide feedback about their experience with the program.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Med-South Lifestyle Program (MSLP) | Experimental | Behavioral: Mediterranean Diet Counseling, Other: Mediterranean Food SupportParticipants receive a 16-week Mediterranean-pattern dietary intervention consisting of individualized dietary counseling, a cooking education module, Mediterranean food support, and printed educational materials. Participants complete in-person study visits at baseline (Week 0) and Week 16, scheduled in conjunction with routine dermatology appointments when possible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Diagnosis of hidradenitis suppurativa confirmed by a board-certified dermatologist
- Hurley stage I, II, or III
- Baseline abscess and inflammatory nodule (AN) count of at least 3, so that disease activity is measurable in every enrolled participant
- Reliable access to Zoom by laptop, tablet, or smartphone
Key exclusion criteria (5 listed)
- Systemic antibiotic use (oral, intramuscular, or intravenous) within 28 days before the planned enrollment visit
- Topical antibiotic use within 5 days before the planned enrollment visit
- Background HS therapy that has not been stable for the 28 days before enrollment, or that is not expected to remain stable through the 16-week study period
- Currently pregnant or breastfeeding
- Unable to complete study procedures in English
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 Diet CounselingAlso: MSLPParticipants receive a 16-week Mediterranean-pattern dietary counseling program delivered primarily by video call. Individual counseling is provided by dietetic students under the supervision of a registered dietitian. Six core sessions occur at Weeks 1, 2, 5, 8, 11, and 14, with five individualized adherence-support contacts at Weeks 3, 6, 9, 12, and 15. Core sessions cover vegetables and fruit; whole grains and legumes; nuts, oils, dressings, and spreads; beverages, desserts, and snacks; eating out and sodium; and fish, meat, poultry, dairy, and eggs. Sessions include progress review, nutrition education, collaborative goal setting, an action plan, and planning for the next contact. A group or recorded cooking education module is completed between Weeks 5 and 8. Printed materials include HS and nutrition summaries, the MSLP manual, and cookbook. | Behavioural | Med-South Lifestyle Program (MSLP) |
| Mediterranean Food SupportParticipants receive Mediterranean-pattern food support during the 16-week intervention to facilitate implementation of the dietary recommendations. At the baseline study visit, participants receive selected Mediterranean pantry staples, including extra-virgin olive oil, herbs, and spices. Home-delivered prepared meals consistent with the intervention dietary pattern are also provided during the study period. Before food is provided, participants complete an allergy and food-intolerance screening. Dietary restrictions and preferences relevant to food provision are reviewed before subsequent deliveries. Receipt of pantry items and meal deliveries is documented, and participants are asked to report the amount of each delivered meal consumed. | Other | Med-South Lifestyle Program (MSLP) |
Primary outcome
Feasibility of Intervention Measure (FIM)
Time frame: Week 16
The Feasibility of Intervention Measure (FIM) is a four-item participant-reported measure of the perceived feasibility of the intervention. Each item is rated on a five-point Likert scale from 1 (completely disagree) to 5 (completely agree), and the four item scores are averaged to give a total score ranging from 1 to 5. Higher scores indicate greater perceived feasibility. Scores will be summarized among participants with available Week 16 responses.The number of participants contributing data will be reported, and missing Week 16 assessments will be reported as missing rather than treated as study exclusions.
2 secondary outcomes
Change in Mediterranean Diet Adherence Screener (MEDAS) Score
Time frame: Week 0 and Week 16
Acceptability of Intervention Measure (AIM)
Time frame: Week 16
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 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results reported in this study will be shared beginning 9 months following article publication and continuing for 36 months, provided that the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
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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.
Christopher J Sayed, MD principal investigator
University of North Carolina, Chapel Hill
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 Diet Counseling and Mediterranean Food Support in people with Hidradenitis Suppurativa, run by University of North Carolina, Chapel Hill 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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?
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 Ray Cheever, BS (984-974-3900, christopher_cheever@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (FIM) (time frame: Week 16). 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 2 Sep 2026.