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Ketogenic Diet in Women With Lipedema

NCT07530341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-04-15

No results posted yet for this study

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. 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.

Conditions

  • Lipedema
  • Overweight and Obesity

Interventions

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.

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-20
Primary Completion
2022-12-22
Completion
2023-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530341 on ClinicalTrials.gov