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LipedemaMLVLEKVTNCT07041684

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

A study testing Very Low Energy Ketogenic Therapy with vegan meal replacements in people with Lipedema and Obesity, run by University of Roma La Sapienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Lipedema, Obesity, Dysbiosis
What is being tested?
Very Low Energy Ketogenic Therapy with vegan meal replacements
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
8 Apr 2024to 23 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • La Sapienza, University of Rome

    Rome, Italy, 00161

Other trials in Italy

About this study

Official 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

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.

Read more

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.

Being tested
Very Low Energy Ketogenic Therapy with vegan meal replacements
Medical subject headings
Lipedema, Obesity, Dysbiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Very Low Energy Ketogenic Therapy with vegan meal replacementsDietary supplement

    Also called Microbiota Analysis

    Metagenomics analysis of gut microbiota at baseline and after 45 days

Study groups in NCT07041684
Study groupRoleWhat they receive
Obese patients with lipedemaExperimentalObese patients with lipedema treated with vegan VLEKT
Receives: Dietary Supplement: Very Low Energy Ketogenic Therapy with vegan meal replacements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 20 partecipants with changes in weight

    weight (kg)

    Measured: From enrollment to the end of treatment at 45 days

  2. 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);

    Measured: From enrollment to the end of tratment at 45 days

  3. 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).

    Measured: From enrollment to the end of treatment at 45 days

  4. 20 partecipants with changes in blood count

    Measured: From enrollment to the end of treatment at 45 days

  5. 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)

    Measured: From enrollment to the end of treatment at 45 days

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

    CPR (mg/L)

    Measured: From enrollment to the end of treatment at 45 days

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

    ESR (mm/h)

    Measured: From enrollment to the end of treatment at 45 days

  8. 20 partecipants with changes in insulin

    insulin (µU/mL)

    Measured: From enrollment to the end of treatment at 45 days

  9. 20 partecipants with changes in HOMA-INDEX

    HOMA-INDEX (threshold of 2.5)

    Measured: From enrollment to the end of treatment at 45 days

  10. 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)

    Measured: From enrollment to the end of treatment at 45 days

  11. 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)

    Measured: From enrollment to the end of treatment at 45 days

  12. 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)

    Measured: From enrollment to the end of treatment at 45 days

  13. 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.

    Measured: From enrollment to the end of treatment at 45 days

  14. 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.

    Measured: From enrollment to the end of treatment at 45 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start8 Apr 2024
  3. Primary completion21 Jun 2024
  4. Study completion23 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07041684
Sponsor's protocol ID
PLK24
Acronym
MLVLEKVT
Status last verified
Dec 2024
First submitted
15 Dec 2024
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Basciani S, Camajani E, Contini S, Persichetti A, Risi R, Bertoldi L, Strigari L, Prossomariti G, Watanabe M, Mariani S, Lubrano C, Genco A, Spera G, Gnessi L. Very-Low-Calorie Ketogenic Diets With Whey, Vegetable, or Animal Protein in Patients With Obesity: A Randomized Pilot Study. J Clin Endocrinol Metab. 2020 Sep 1;105(9):dgaa336. doi: 10.1210/clinem/dgaa336.

    PubMed 32484877
  • Keith L, Seo CA, Rowsemitt C, Pfeffer M, Wahi M, Staggs M, Dudek J, Gower B, Carmody M. Ketogenic diet as a potential intervention for lipedema. Med Hypotheses. 2021 Jan;146:110435. doi: 10.1016/j.mehy.2020.110435. Epub 2020 Nov 27.

    PubMed 33303304
  • Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.

    PubMed 31111407

Questions about this trial

What is this clinical trial studying?

A study testing Very Low Energy Ketogenic Therapy with vegan meal replacements in people with Lipedema and Obesity, run by University of Roma La Sapienza at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

20 partecipants with changes in weight (time frame: From enrollment to the end of treatment at 45 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07041684, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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