Mediterranean Dietary Intervention for HS

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor: University of North Carolina, Chapel Hill
Study ID: NCT07800416
Status: Not Yet Recruiting

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Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

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.
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.

Study Details

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.

Key Dates

First listed: Sep 2, 2026
Start date: Sep 30, 2026
Status verified: Aug 2026
Primary completion: Aug 31, 2027
Completion: Aug 31, 2027

Study Design

Enrollment: 30 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Arms

Experimental: Med-South Lifestyle Program (MSLP)
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.