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LipedemaNCT07530341

Ketogenic Diet in Women With Lipedema

A study testing Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties in people with Lipedema and Overweight and Obesity, run by Wroclaw Medical University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Lipedema, Overweight and Obesity
What is being tested?
Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 sitePoland
Study dates
20 Feb 2020to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • consent to participate in the study
  • diagnosis of lipedema proved by an angiologist
  • overweight or obesity based on BMI>25 kg/m2

Who cannot join

  • pregnancy and period of 6 months after pregnancy,
  • breastfeeding,
  • diagnosis of lymphedema,
  • edema in the course of chronic vein insufficiency or heart failure,
  • diabetes mellitus,
  • kidney or liver failure,
Show all 10Show fewer
  • hormonally unbalanced thyroid disease,
  • cancer
  • implanted cardiac devices (cardiac pacemaker, implantable cardioverter-defibrillator, resynchronization therapy)
  • metal implants

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Wroclaw Medical University

    Wroclaw, Lower Silesian Voivodeship, 50-367

Other trials in Poland

About this study

Official title: 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

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.

Read the detailed description

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:

  1. Measurement of anthropometric parameters:
  • height - A TANITA HR-001 growth meter (Tanita, Tokyo, Japan)
  • weight and body composition parameters (body fat, lean body mass, body water, visceral fat) - A TANITA MC-780MA (Tanita, Tokyo, Japan)
  • waist, hip and leg circumferences (at 4 cm intervals from the ankle to the groin on the side of the leg) - standard tape measure to the nearest 1 cm
  1. Questionnaires:
  • assessment of pain level in the leg - visual analogue scale (VAS)
  • assessment of psychological status, symptoms and quality of life:
  • The World Health Organization Disability Assessment Schedule (WHO-DAS II)
  • Beck's Depression Inventory - II (BDI-II)
  • The Hospital Anxiety and Depression Scale (HADS)
  • symptoms of the lower extremities (LYMQOL)
  • distress symptoms (GHQ28)
  • quality of life (SF-36)
  • assessment of food consuming - Food Frequency Questionnaire (FFQ)
  1. Blood samples collection:
  • collection of approximately 25 ml of peripheral blood for laboratory tests
  • adipose tissue hormones: adiponectin, leptin, resistin, visfatin, and vaspin
  • oxidative stress markers: lipid peroxidation (TBARS)TBARS, 8-iso-prostaglandin F2α concentration, protein carbonyl content, serum total antioxidant capacity (TAC), superoxide dismutase (SOD) activity, catalase (CAT) activity, serum antioxidant vitamins (C, A and E)
  • angiogenic and lymphangiogenic factors: VEGF-A, VEGF-C, VEGF-D, angiopoietin-2, sICAM-1, sVCAM-1, P-selectin
  • endothelial adhesion molecules: sVCAM-1, sICAM-1, P-selectin
  • inflammatory cytokines: TNF-α, IL-1β, IL-8, IL-10, IL-13, CRP
  • targeted metabolomics: selected eicosanoids, endocannabinoids, and nitric oxide metabolites
  1. Fat samples collection from the subcutaneous fatty tissue • collection of a drop subcutaneous fat from the thigh for metabolomic tests:
  • angiogenic and lymphangiogenic factors: VEGF-A, VEGF-C, VEGF-D, angiopoietin-2, sICAM-1, sVCAM-1, P-selectin
  • endothelial adhesion molecules: sVCAM-1, sICAM-1, P-selectin
  • inflammatory cytokines: TNF-α, IL-1β, IL-8, IL-10, IL-13
  • targeted metabolomics: selected eicosanoids, endocannabinoids, and nitric oxide metabolites

Of the original study population, 48 patients completed the study (28 in the lipedema group and 24 with overweight/obesity).

Being tested
Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties
Keywords
lipedema, ketogenic diet, inflammation, metabolomics, angiogenesis, personalized nutrition, lymphatic function
Medical subject headings
Lipedema, Overweight, Obesity, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT07530341
Study groupRoleWhat they receive
Patients with lipedema (interventional group)ExperimentalPatients with diagnosis of lipedema who following the interventional (ketogenic) diet.
Receives: Behavioral: Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties
Patients with overweight/obesity (control group)ExperimentalPatients with overweight/obesity (BMI > 25 kg/m2) without lipedema symptoms who following the interventional (ketogenic) diet.
Receives: Behavioral: Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in leg circumferences

    Changes in leg circumferences between 2 timepoints (baseline and end of study)

    Measured: Up to 7 months

Secondary outcomes (42)

  1. Change in body weight

    Change in body weight in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  2. Change in body fat

    Change in body fat percentage (%) measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  3. 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).

    Measured: Up to 7 months

  4. Change in body water

    Change in body water in kilograms measured using bioelectrical impedance analysis between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  5. 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).

    Measured: Up to 7 months

  6. 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).

    Measured: Up to 7 months

  7. 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).

    Measured: Up to 7 months

  8. 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).

    Measured: Up to 7 months

  9. 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).

    Measured: Up to 7 months

  10. 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).

    Measured: Up to 7 months

  11. 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).

    Measured: Up to 7 months

  12. 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.

    Measured: Up to 7 months

  13. Change in leptin concentration

    Change in serum leptin concentration [ng/ml] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  14. Change in adiponectin concentration

    Change in serum adiponectin concentration [ng/ml] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  15. Change in resistin concentration

    Change in serum resistin concentration [pg/ml] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  16. Change in vaspin concentration

    Change in serum vaspin concentration [pg/ml] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  17. Change in visfatin concentration

    Change in serum visfatin concentration [ng/ml] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  18. Change in TNF-α concentration

    Change in serum tumor necrosis factor-alpha (TNF-α) concentration measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  19. Change in IL-1β concentration

    Change in serum interleukin-1 beta (IL-1β) concentration measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  20. Change in IL-8 concentration

    Change in serum interleukin-8 (IL-8) concentration measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  21. Change in IL-10 concentration

    Change in serum interleukin-10 (IL-10) concentration measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  22. Change in IL-13 concentration

    Change in serum interleukin-13 (IL-13) concentration measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  23. Change in CRP concentration

    Change in serum C-reactive protein (CRP) concentration measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  24. Change in TBARS concentration

    Change in serum thiobarbituric acid reactive substances (TBARS) concentration [µmol/l] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  25. 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).

    Measured: Up to 7 months

  26. Change in protein carbonyl content

    Change in serum protein carbonyl content [nmol/mg protein] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  27. 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).

    Measured: Up to 7 months

  28. Change in SOD activity

    Change in serum superoxide dismutase (SOD) [U/ml] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  29. Change in CAT activity

    Change in serum catalase (CAT) [U/ml] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  30. Change in vitamin C concentration

    Change in serum vitamin C concentration [µmol/l] measured between 2 timepoints (baseline and end of study).

    Measured: Up to months

  31. Change in vitamin A concentration

    Change in serum vitamin A concentration [µmol/l] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  32. Change in vitamin E concentration

    Change in serum vitamin E concentration [µmol/l] measured between 2 timepoints (baseline and end of study).

    Measured: Up to 7 months

  33. 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).

    Measured: Up to 7 months

  34. 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).

    Measured: Up to 7 months

  35. 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).

    Measured: Up to months

  36. 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).

    Measured: Up to 7 months

  37. 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).

    Measured: Up to 7 months

  38. 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).

    Measured: Up to 7 months

  39. 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).

    Measured: Up to 7 months

  40. 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]

    Measured: Up to 7 months

  41. 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]

    Measured: Up to 7 months

  42. 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)

    Measured: Up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start20 Feb 2020
  3. Primary completion22 Dec 2022
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Experimental Arm Control Arm
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07530341
Sponsor's protocol ID
WroclawMJ
Status last verified
Mar 2026
First submitted
30 Mar 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties in people with Lipedema and Overweight and Obesity, run by Wroclaw Medical University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in leg circumferences (time frame: Up to 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07530341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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