Microbiota and Lipedema Evaluation in Obese Patient Treated With Very Low Energy Ketogenic Vegan Therapy (MLVLEKVT)

July 7, 2025 updated by: Lucio Gnessi, University of Roma La Sapienza

Microbiota and Lipedema: Weight Loss, Metabolic and Inflammatory Pattern, and Quality of Life in Obese Patients Before and After Treatment With Very Low Energy Ketogenic Vegan Therapy

Lipedema is a progressive, hereditary, multifactorial disease that occurs primarily in women, characterized by an abnormal and painful accumulation of subcutaneous fatty tissue. The etiology of lipedema is not entirely clear, but genetic, hormonal, vascular, and lymphatic factors have been implicated. Recent research suggests a potential role of the gut microbiota in the etiopathogenesis and progression of the disease, as alterations in gut microbial composition (dysbiosis) could contribute to chronic systemic inflammation and metabolic dysfunction that exacerbate the fat deposition typical of lipedema.

The condition is often associated with obesity, contributing to a state of chronic inflammation that exacerbates its progression. Among management strategies, Very Low Energy Ketogenic Therapy (VLEKT) has been proposed for its potential in improving inflammation and metabolism. VLEKT, an extremely low-calorie dietary regimen that induces ketosis through carbohydrate reduction, has been studied primarily for weight management, but the adoption of a plant-protein variant could offer additional benefits due to their anti-inflammatory properties resulting primarily from positive modulation of the gut microbiota.

The purpose of this study was to evaluate the effects of a plant protein-based ketogenic diet on the composition of the gut microbiota of obese patients with lipedema and to observe how it affected the symptoms of the condition. This experimental study analyzed anthropometric, metabolic, inflammatory parameters and the gut microbiota, as well as quality of life. The results obtained made it possible to evaluate the effectiveness of this dietary approach in the context of lipedema management, emphasizing the role of the gut microbiota and the anti-inflammatory properties of plant proteins. However, the single-center nature and limited number of participants represent limitations for generalizing the results.

Methods The present work is a prospective experimental study, in which a participant group consisting of 20 female individuals with lipedema were observed and offered plant protein-based VLEKT. Patients chosen to participate in the study were identified according to the following eligibility criteria: female subjects aged >18 years with a diagnosis of clinical stage II-III lipedema and with prior dietary treatment.

The presence of any of the following conditions prevented their enrollment in the study: subjects without an indication for treatment or unable to undergo VLEKT treatment; pregnancy and lactation; treatment with drugs interfering with proper microbiota analysis; and male subjects.

Each subject participating in the study underwent an initial outpatient specialist examination, and through the medical history, the following data were collected: age, sex, general and pathological health condition, and hematochemical parameters paying attention especially to CRP, blood glucose, insulin, total and HDL cholesterol, and triglycerides. Anthropometric parameters were then taken, including: weight; height; waist circumference; hip circumference; right and left thigh circumference; right and left arm circumference; right and left calf circumference; and right and left ankle circumference.

Once the anthropometric data were recorded, body composition analysis was conducted, which allowed the assessment of parameters such as: total water (TBW); extracellular water (ECW); intracellular water (ICW); lean body mass (FFM); and fat mass (FM).

Each patient received a fecal sample extraction kit in order to perform gut microbiota analysis. The same data were collected again at the end of the study after 45 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00161
        • La Sapienza, University of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI ≥ 30
  • Female subjects aged > 18 years
  • With a diagnosis of lipedema (II - III clinical stage)

Exclusion Criteria:

  • Subjects without an indication for treatment
  • Subjects who cannot undergo VLCKD treatment
  • Pregnancy and lactation
  • Treatment with drugs that interfere with proper microbiota analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obese patients with lipedema
Obese patients with lipedema treated with vegan VLEKT
Dietary supplement: Very Low Energy Ketogenic Therapy with vegan meal replacements
Metagenomics analysis of gut microbiota at baseline and after 45 days
Other Names:
  • Microbiota Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
20 partecipants with changes in blood count
Time Frame: From enrollment to the end of treatment at 45 days
From enrollment to the end of treatment at 45 days
20 partecipants with changes in blood glucose, total and HDL cholesterol, and triglycerides
Time Frame: From enrollment to the end of treatment at 45 days
blood glucose (mg/dL), total and HDL cholesterol (mg/dL), and triglycerides (mg/dL)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in c-reactive protein (CPR)
Time Frame: From enrollment to the end of treatment at 45 days
CPR (mg/L)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in erythrocyte sedimentation rate (ESR)
Time Frame: From enrollment to the end of treatment at 45 days
ESR (mm/h)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in insulin
Time Frame: From enrollment to the end of treatment at 45 days
insulin (µU/mL)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in HOMA-INDEX
Time Frame: From enrollment to the end of treatment at 45 days
HOMA-INDEX (threshold of 2.5)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in body water (Total Body Water, Extracellular Water, Intracellular Water) by means of bioimpedance analysis (Akern BIVA 101)
Time Frame: From enrollment to the end of treatment at 45 days
Total Body Water (L), Extracellular Water (L), Intracellular Water (L)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in Free Fat Mass, Fat Mass, Body Cell Mass by means of bioimpedance analysis (Akern BIVA 101)
Time Frame: From enrollment to the end of treatment at 45 days
Free Fat Mass (Kg), Fat Mass (Kg), Body Cell Mass (Kg)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in Skeletal Muscle Index by means of bioimpedance analysis (Akern BIVA 101)
Time Frame: From enrollment to the end of treatment at 45 days
Skeletal Muscle Index (>7,0 kg/m^2 in men and >5,7 kg/m^2 in women)
From enrollment to the end of treatment at 45 days
Short form of the McGill Pain Questionnaire (SF-MPQ)
Time Frame: From enrollment to the end of treatment at 45 days
The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ and a visual analogue scale (VAS) from 0-100, where 100 is fort pain.
From enrollment to the end of treatment at 45 days
EuroQoL 5D (EQ-5D)
Time Frame: From enrollment to the end of treatment at 45 days
The EQ-5D consists of five questions (also known as dimensions (5D): mobility, selfcare, usual activities, pain/discomfort, anxiety/depression) with 5 levels (5L) of problem severity in the responses, as well as a Visual Analogue Scale (EQ-VAS) aiming to capture a respondents' rating of their 'health today' on a scale from 0-100, where 100 is better health condition.
From enrollment to the end of treatment at 45 days
20 partecipants with changes in weight
Time Frame: From enrollment to the end of treatment at 45 days
weight (kg)
From enrollment to the end of treatment at 45 days
20 partecipants with changes in BMI
Time Frame: From enrollment to the end of tratment at 45 days
BMI - Body Mass Index (weight and height will be combined to report BMI in kg/m^2) whose ranges are: underweight (<18.5), normal weight (18.5-24.9), overweight (25-29.9), obesity (30 or more);
From enrollment to the end of tratment at 45 days
20 partecipants with changes in circumferences
Time Frame: From enrollment to the end of treatment at 45 days
waist circumference (cm); hip circumference (cm); right and left thigh circumference (cm); right and left arm circumference (cm); right and left calf circumference (cm); and right and left ankle circumference (cm).
From enrollment to the end of treatment at 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

Campus Bio-Medico University

Investigators

  • Principal Investigator: Lucio Gnessi, Medical Doctor, University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Actual)

June 21, 2024

Study Completion (Actual)

September 23, 2024

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

June 18, 2025

First Posted (Actual)

June 27, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLK24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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