NCT07530341Completed
Ketogenic Diet in Women With Lipedema
Effect of a Low-Carbohydrate, High-Fat (LCHF) Ketogenic Diet on Adipose Tissue Hormones, Oxidative Stress, Inflammation, Lymphatic and Angiogenic Factors, Metabolomics, Symptoms, and Quality of Life in Women With Lipedema
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 121 (actual)
- First submitted
- 30 Mar 2026
- Start date
- 20 Feb 2020
- Primary completion date
- 22 Dec 2022
- Lead sponsor
- Wroclaw Medical University
- Diseases
- Obesity
- NCT number
- NCT07530341
What you commit to
- Study type: Interventional
- Participants enrolled: 121
- From 20 Feb 2020 to the primary completion date, 22 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- metal implants
Other illness
- edema in the course of chronic vein insufficiency or heart failure,
- diabetes mellitus,
- kidney or liver failure,
- hormonally unbalanced thyroid disease,
- cancer
- implanted cardiac devices (cardiac pacemaker, implantable cardioverter-defibrillator, resynchronization therapy)
Other
- pregnancy and period of 6 months after pregnancy,
- breastfeeding,
- diagnosis of lymphedema,
Who the study is looking for
- consent to participate in the study
- diagnosis of lipedema proved by an angiologist
- overweight or obesity based on BMI\>25 kg/m2
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wroclaw Medical University Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.