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

NCT ID: NCT07041684

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2024-09-23

Brief 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. 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.

Conditions

Lipedema; Obesity; Dysbiosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Obese patients with lipedema

Obese patients with lipedema treated with vegan VLEKT

Group Type: EXPERIMENTAL

Very Low Energy Ketogenic Therapy with vegan meal replacements

Intervention Type: DIETARY_SUPPLEMENT

Metagenomics analysis of gut microbiota at baseline and after 45 days

Interventions

Very Low Energy Ketogenic Therapy with vegan meal replacements

Metagenomics analysis of gut microbiota at baseline and after 45 days

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Microbiota Analysis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Lucio Gnessi

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucio Gnessi, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

La Sapienza, University of Rome

Rome, Italy, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 32484877 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33303304 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31111407 (View on PubMed)

Other Identifiers

PLK24

Identifier Type: -

Identifier Source: org_study_id