Mediterranean Dietary Intervention for HS

NCT07800416 | Not Yet Recruiting

• 1 other identifier: 26-0451
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hidradenitis Suppurativa

Keywords

Mediterranean diet; Feasibility study; Dietary counseling; Pilot study

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 16

Secondary Outcomes (2)

• Change in Mediterranean Diet Adherence Screener (MEDAS) Score

  Week 0 and Week 16

• Acceptability of Intervention Measure (AIM)

  Week 16

Study Arms (1)

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.

Behavioral: Mediterranean Diet Counseling; Other: Mediterranean Food Support

Interventions

Mediterranean Diet Counseling BEHAVIORAL

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.

Also known as: MSLP

Med-South Lifestyle Program (MSLP)

Mediterranean Food Support OTHER

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.

Med-South Lifestyle Program (MSLP)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Hidradenitis Suppurativa Foundation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Dermatology

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Christopher J Sayed, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray Cheever, BS

CONTACT

984-974-3900; christopher_cheever@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 9 months following article publication and continuing for 36 months.
• Access Criteria: Requesting investigators must have approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.

Locations

US (1)