Skip to main content
OpenTrials
Completed

NCT Number: NCT07041684

Microbiota and Lipedema Evaluation in Obese Patient Treated 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lipedema Body Weight Connective Tissue Diseases Dysbiosis Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

La Sapienza, University of Rome

Rome, Italy, 00161

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very Low Energy Ketogenic Therapy with vegan meal replacements

Dietary Supplement

Metagenomics analysis of gut microbiota at baseline and after 45 days

Other names: Microbiota Analysis

Primary outcomes

  1. 20 partecipants with changes in weight

    Time frame: From enrollment to the end of treatment at 45 days

    weight (kg)

  2. 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);

  3. 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).

  4. 20 partecipants with changes in blood count

    Time frame: From enrollment to the end of treatment at 45 days

  5. 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)

  6. 20 partecipants with changes in c-reactive protein (CPR)

    Time frame: From enrollment to the end of treatment at 45 days

    CPR (mg/L)

  7. 20 partecipants with changes in erythrocyte sedimentation rate (ESR)

    Time frame: From enrollment to the end of treatment at 45 days

    ESR (mm/h)

  8. 20 partecipants with changes in insulin

    Time frame: From enrollment to the end of treatment at 45 days

    insulin (µU/mL)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Campus Bio-Medico University

Registry information

Official study title

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

Acronym: MLVLEKVT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.