An interventional study of Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties in Lipedema and Overweight and Obesity, sponsored by Wroclaw Medical University. Completed at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Wroclaw Medical University · Not applicable, Interventional, and Basic science
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.
A total of 121 women were invited to participate in the study. The study group consisted of patients from the Angiology Outpatient Clinic at Wroclaw Medical University in Poland with the diagnosis of lipedema made by an angiologist (n=66). The control volunteer group was composed of women with overweight or obesity (body mass index, BMI= 25 kg/m2) who were not affected by lipedema (n=55).
All participants recruited to the study underwent following procedures at the beginning and at the end of the study:
Measurement of anthropometric parameters:
Questionnaires:
assessment of psychological status, symptoms and quality of life:
Blood samples collection:
Fat samples collection from the subcutaneous fatty tissue • collection of a drop subcutaneous fat from the thigh for metabolomic tests:
Of the original study population, 48 patients completed the study (28 in the lipedema group and 24 with overweight/obesity).
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 121 is above the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with diagnosis of lipedema who following the interventional (ketogenic) diet.
Behavioral: Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties
Patients with overweight/obesity (BMI \> 25 kg/m2) without lipedema symptoms who following the interventional (ketogenic) diet.
Behavioral: Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties
The interventional diet structure was similar to a typical ketogenic diet, with less than 50 g of carbohydrates per day. The diet was designed as a Mediterranean style with many food products with anti-inflammatory properties such as antioxidants, unsaturated fatty acids, herbs, spices, tea and coffee. The diet was reduced in saturated fatty acids and processed foods. All the involved participants received the personalized caloric-restricted low-carbohydrate high-fat (ketogenic) diet, based on the patient's preferences. The daily energy intake was divided into 3 meals, consisting of a source of protein, fat, and vegetable additives. They received individual 7-day meal plans to repeat for 7 months with recipes and a shopping list. The personalization of the dietary plans aimed to increase compliance with the diets. Additionally, each patient received detailed dietary recommendations that facilitated adherence to the dietary plan.
Change in leg circumferences
Changes in leg circumferences between 2 timepoints (baseline and end of study)
Time frame: Up to 7 months
Change in body weight
Change in body weight in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in body fat
Change in body fat percentage (%) measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in lean body mass
Change in lean body mass in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in body water
Change in body water in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in visceral fat level
Change in visceral fat level measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study). Visceral fat level is measured on a scale from 1 (lowest level) to 20 (highest level).
Time frame: Up to 7 months
Change in disability level
Change in disability level measured using the World Health Organization Disability Assessment Schedule II (WHO-DAS II) total score between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in depressive symptoms
Change in depressive symptoms measured using the Beck Depression Inventory-II (BDI-II) total score between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in anxiety and depression symptoms
Change in anxiety and depression symptoms measured using the Hospital Anxiety and Depression Scale (HADS) total score between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in lower extremity symptoms
Change in lower extremity symptoms measured using the Lymphedema Quality of Life Questionnaire (LYMQOL) total score between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in psychological distress
Change in psychological distress measured using the General Health Questionnaire (GHQ-28) total score between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in quality of life
Change in quality of life measured using the Short Form Health Survey (SF-36) total score between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in pain intensity in the legs
Change in pain intensity assessed using the Visual Analogue Scale (VAS) between 2 timepoints (baseline and end of study). Pain intensity is measured using the VAS, a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: Up to 7 months
Change in leptin concentration
Change in serum leptin concentration \[ng/ml\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in adiponectin concentration
Change in serum adiponectin concentration \[ng/ml\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in resistin concentration
Change in serum resistin concentration \[pg/ml\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in vaspin concentration
Change in serum vaspin concentration \[pg/ml\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in visfatin concentration
Change in serum visfatin concentration \[ng/ml\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in TNF-α concentration
Change in serum tumor necrosis factor-alpha (TNF-α) concentration measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in IL-1β concentration
Change in serum interleukin-1 beta (IL-1β) concentration measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in IL-8 concentration
Change in serum interleukin-8 (IL-8) concentration measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in IL-10 concentration
Change in serum interleukin-10 (IL-10) concentration measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in IL-13 concentration
Change in serum interleukin-13 (IL-13) concentration measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in CRP concentration
Change in serum C-reactive protein (CRP) concentration measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in TBARS concentration
Change in serum thiobarbituric acid reactive substances (TBARS) concentration \[µmol/l\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in 8-iso-prostaglandin F2α concentration
Change in serum 8-iso-prostaglandin F2α concentration \[pg/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in protein carbonyl content
Change in serum protein carbonyl content \[nmol/mg protein\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in total antioxidant capacity
Change in serum total antioxidant capacity (TAC) \[mmol Trolox eqiv./l\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in SOD activity
Change in serum superoxide dismutase (SOD) \[U/ml\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in CAT activity
Change in serum catalase (CAT) \[U/ml\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in vitamin C concentration
Change in serum vitamin C concentration \[µmol/l\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to months
Change in vitamin A concentration
Change in serum vitamin A concentration \[µmol/l\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in vitamin E concentration
Change in serum vitamin E concentration \[µmol/l\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in VEGF-A concentration
Change in serum and subcutaneous tissue VEGF-A concentration \[pg/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in VEGF-C concentration
Change in serum and subcutaneous tissue VEGF-C concentration \[pg/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in VEGF-D concentration
Change in serum and subcutaneous tissue VEGF-D concentration \[pg/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to months
Change in angiopoietin-2 concentration
Change in serum and subcutaneous tissue angiopoietin-2 concentration \[pg/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in sICAM-1 concentration
Change in serum and subcutaneous tissue soluble ICAM-1 (sICAM-1) concentration \[ng/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in sVCAM-1 concentration
Change in serum and subcutaneous tissue soluble VCAM-1 (sVCAM-1) concentration \[ng/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in P-selectin concentration
Change in serum and subcutaneous tissue p-selectin concentration \[pg/mL\] measured between 2 timepoints (baseline and end of study).
Time frame: Up to 7 months
Change in eicosanoids concentrations
Change in serum/plasma concentrations of selected eicosanoids measured between 2 timepoints (baseline and end of study) using targeted metabolomics (ng/mL): * 13,14-dihydro Prostaglandin E1 \[ng/mL\] * 15-deoxy-Δ12,14-Prostaglandin J2 \[ng/mL\] * Prostaglandin D2 \[ng/mL\] * Prostaglandin E2 \[ng/mL\] * 6-keto Prostaglandin F1α \[ng/mL\] * Prostaglandin F2α \[ng/mL\] * Leukotriene B4 \[ng/mL\] * Thromboxane B2 \[ng/mL\]
Time frame: Up to 7 months
Change in endocannabinoids concentrations
Change in serum/plasma concentrations of selected endocannabinoids concentrations measured between 2 timepoints (baseline and end of study) using targeted metabolomics (ng/mL): * Arachidonoyl ethanolamide (AEA) \[ng/mL\] * Oleoyl ethanolamide (OEA) \[ng/mL\] * Palmitoyl ethanolamide (PEA) \[ng/mL\] * 1-Arachidonoyl glycerol (1-AG) \[ng/mL\] * 2-Arachidonoyl glycerol (2-AG) \[ng/mL\]
Time frame: Up to 7 months
Change in nitric oxide metabolites concentrations
Change in serum/plasma concentrations of selected nitric oxide metabolites concentrations measured between 2 timepoints (baseline and end of study) using targeted metabolomics (µmol/L): * asymmetric dimethylargininine (ADMA) * symmetric dimethylargininine (SDMA)
Time frame: Up to 7 months
Plan to share: No — All data used to support the findings of this study are available from the corresponding author upon reasonable request due to the privacy of patients.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Wroclaw Medical University