Personalized anti-inflammatory diet plus physical therapy for lipedema in women
Official title: Efficacy of Complex Decongestive Therapy, Exercise, and Nutritional Interventions in Women Diagnosed With Lipedema: A Prospective, Single-Blind, Randomized Controlled Trial
Run by Balikesir University · NCT07667270 · Data updated 2026-11-12
This study tests whether adding a personalized anti-inflammatory diet to standard physical therapy helps women with lipedema improve leg size, pain, and quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 75 (estimated) |
| Sponsor | Balikesir University Academic / other |
| Locations | 1 site (Balıkesir) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | December 15, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07667270 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–65 with stage I–III lipedema, BMI under 45, able to walk without assistance, and able to adhere to the study schedule.
✕Probably not a fit
Participants with advanced comorbidities or low adherence may see limited or no benefit from the nutritional intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized, single-blind trial will compare two nutrition approaches combined with a 12-week physical therapy program that includes Complex Decongestive Therapy, pneumatic compression, and exercise. Seventy-five women with stage I–III lipedema will be randomized to receive either a personalized anti-inflammatory diet or standard nutrition education, alongside standard physical therapy. Outcomes are measured at baseline, week 4, week 8, and week 12, including leg circumference/volume, body composition, ultrasound tissue characteristics, functional capacity, pain, and quality of life. Primary endpoints focus on anatomical and functional improvements, while secondary endpoints capture patient-reported outcomes and tolerability of the protocols.
Why it matters
Potential benefit: If successful, the approach could offer a more effective way to reduce leg swelling and improve daily function and comfort for women with lipedema.
How similar studies have gone: Previous work suggests integrated physical therapy can help lipedema, and dietary approaches may influence inflammation; however, this exact combination is relatively novel in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, aged 18 to 65 years. * Clinical and physical examination confirming Stage I, II, or III lipedema. * Body Mass Index (BMI) \< 45 kg/m\^2. * Ability to walk without restriction. Exclusion Criteria: * Presence of active malignancy. * Decompensated heart failure. * Significant lower extremity peripheral artery disease. * Acute deep vein thrombosis or active thromboembolism. * Pregnancy. * Significant sensory loss or severe neuropathy in the lower extremities. * History of lower extremity liposuction within the last 12 months. * Active severe infection (e.g., cellulitis). * Other severe systemic diseases deemed unsafe for the study by researchers. * Severe non-compliance with the study protocol (e.g., missing \>30% of planned sessions) or participant requesting withdrawal.
Where it's running
-
Balikesir University Faculty of Medicine Hospital
Balıkesir, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Nilay Sahin, Prof. Dr. — Balikesir University
- Study coordinator: Nilay Sahin, Prof. Dr.
- Email: dincernilay@yahoo.com
- Phone: +90 555 233 2535
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.