NCT07530341

Ketogenic Diet in Women With Lipedema

Completed NA Last updated 15 April 2026

What this trial tests

NA trial testing Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties in Lipedema in 121 participants. Completed in 31 December 2023.

Timeline

20 February 2020

Primary endpoint
22 December 2022

31 December 2023

Quick facts

Lead sponsor	Wroclaw Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	121
Start date	20 February 2020
Primary completion	22 December 2022
Estimated completion	31 December 2023
Sites	1 location across Poland

Drugs / interventions tested

• Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties

Conditions studied

• Lipedema — all drugs for Lipedema →
• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Wroclaw Medical University

Who can join

18 and older, female only, with Lipedema or Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lipedema is a chronic fat tissue disorder that usually affects the lower limbs, excluding the feet. Clinical symptoms of lipedema include a noticeable disproportion between the upper and lower body, a tendency to easy bruising, and pain in the fatty tissue. It is a common disorder that occurs almost exclusively in women, potentially affecting around 11% of the adult population worldwide. The disease, especially in its advanced stages, has negative psychosocial consequences, leading to social isolation or depression, among other issues. The etiology of the disease is unknown, but genetic, hormonal, and inflammatory factors are likely involved in its pathogenesis. This disorder is characterized by the presence of low-grade inflammation in the fat tissue. The use of reduction diets combined with physical activity or bariatric surgery does not constitute an effective therapeutic approach for lipedema. Recent interventional studies show that an anti-inflammatory ketogenic diet leads to a reduction in leg volume and lipedema symptoms, including pain in the extremities.

This study aims to evaluate clinical, metabolic, inflammatory, and vascular characteristics in women with lipedema and to assess potential changes associated with dietary intervention - 7 months of ketogenic diet (low carbohydrate, high fat).

Participants undergo clinical, laboratory, and patient-reported outcome assessments to evaluate anthropometric parameters, quality of life, and selected biomarkers. The findings are expected to improve understanding of the biological mechanisms underlying lipedema and to support the development of targeted therapeutic strategies.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Changes in Vascular, Lymphatic, Inflammatory, and Lipid Mediators During a 7-Month Calorie-Restricted Low-Carbohydrate, High-Fat Dietary Intervention in Women with Lipedema: A Preliminary Prospective Study.
   Chachaj A, Fleszar M, Lewandowski Ł, Fortuna P, et al · · 2026 · PMID 42123982 · DOI 10.3390/nu18091381