An interventional study of Very Low Energy Ketogenic Therapy with vegan meal replacements in Lipedema, Obesity and Dysbiosis, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 20 is below the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Microbiota Analysis
20 partecipants with changes in weight
weight (kg)
Time frame: From enrollment to the end of treatment at 45 days
20 partecipants with changes in BMI
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);
Time frame: From enrollment to the end of tratment at 45 days
20 partecipants with changes in circumferences
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).
Time frame: From enrollment to the end of treatment at 45 days
20 partecipants with changes in blood count
Time frame: From enrollment to the end of treatment at 45 days
20 partecipants with changes in blood glucose, total and HDL cholesterol, and triglycerides
blood glucose (mg/dL), total and HDL cholesterol (mg/dL), and triglycerides (mg/dL)
Time frame: From enrollment to the end of treatment at 45 days
20 partecipants with changes in c-reactive protein (CPR)
CPR (mg/L)
Time frame: From enrollment to the end of treatment at 45 days
20 partecipants with changes in erythrocyte sedimentation rate (ESR)
ESR (mm/h)
Time frame: From enrollment to the end of treatment at 45 days
20 partecipants with changes in insulin
insulin (µU/mL)
Time frame: From enrollment to the end of treatment at 45 days
20 partecipants with changes in HOMA-INDEX
HOMA-INDEX (threshold of 2.5)
Time frame: 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)
Total Body Water (L), Extracellular Water (L), Intracellular Water (L)
Time frame: 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)
Free Fat Mass (Kg), Fat Mass (Kg), Body Cell Mass (Kg)
Time frame: 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)
Skeletal Muscle Index (\>7,0 kg/m\^2 in men and \>5,7 kg/m\^2 in women)
Time frame: From enrollment to the end of treatment at 45 days
Short form of the McGill Pain Questionnaire (SF-MPQ)
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.
Time frame: From enrollment to the end of treatment at 45 days
EuroQoL 5D (EQ-5D)
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.
Time frame: From enrollment to the end of treatment at 45 days
Plan to share: No
Ran from Apr 2024 to primary completion in Jun 2024, 2 months.
Of 29 interventional studies with no phase under Lipedema, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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