Ketogenic Diet in Women With Lipedema

NCT07530341 | Completed

• 1 other identifier: WroclawMJ
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lipedema; ketogenic diet; inflammation; metabolomics; angiogenesis; personalized nutrition; lymphatic function

Outcome Measures

Primary Outcomes (1)

• Change in leg circumferences

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

  Up to 7 months

Secondary Outcomes (42)

• Change in body weight

  Up to 7 months

• Change in body fat

  Up to 7 months

• Change in lean body mass

  Up to 7 months

• Change in body water

  Up to 7 months

• Change in visceral fat level

  Up to 7 months

Study Arms (2)

Patients with lipedema (interventional group)

EXPERIMENTAL

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 (control group)

EXPERIMENTAL

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

Interventions

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

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.

Patients with lipedema (interventional group); Patients with overweight/obesity (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,
• hormonally unbalanced thyroid disease,
• cancer
• implanted cardiac devices (cardiac pacemaker, implantable cardioverter-defibrillator, resynchronization therapy)
• metal implants

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

MeSH Terms

Conditions

Lipedema; Overweight; Obesity; Inflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental Arm Control Arm

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 15, 2026
• Study Start: February 20, 2020
• Primary Completion: December 22, 2022
• Study Completion: December 31, 2023
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)