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

NCT07041684 | Completed

• 1 other identifier: PLK24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (14)

• 20 partecipants with changes in weight

  weight (kg)

  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);

  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).

  From enrollment to the end of treatment at 45 days

• 20 partecipants with changes in blood count

  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)

  From enrollment to the end of treatment at 45 days

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

  CPR (mg/L)

  From enrollment to the end of treatment at 45 days

• 20 partecipants with changes in erythrocyte sedimentation rate (ESR)

  ESR (mm/h)

  From enrollment to the end of treatment at 45 days

• 20 partecipants with changes in insulin

  insulin (µU/mL)

  From enrollment to the end of treatment at 45 days

• 20 partecipants with changes in HOMA-INDEX

  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)

  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)

  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)

  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)

  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)

  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

Study Arms (1)

Obese patients with lipedema

EXPERIMENTAL

Obese patients with lipedema treated with vegan VLEKT

Dietary Supplement: Very Low Energy Ketogenic Therapy with vegan meal replacements

Interventions

Very Low Energy Ketogenic Therapy with vegan meal replacements DIETARY_SUPPLEMENT

Metagenomics analysis of gut microbiota at baseline and after 45 days

Also known as: Microbiota Analysis

Obese patients with lipedema

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Campus Bio-Medico University: collaborator

Study Sites (1)

La Sapienza, University of Rome

Rome, Italy, 00161, Italy

Location

Related Publications (3)

• 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.

  PMID: 32484877 BACKGROUND

• 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.

  PMID: 33303304 BACKGROUND

• 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.

  PMID: 31111407 BACKGROUND

MeSH Terms

Conditions

Lipedema; Obesity; Dysbiosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Lucio Gnessi, Medical Doctor

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: June 27, 2025
• Study Start: April 8, 2024
• Primary Completion: June 21, 2024
• Study Completion: September 23, 2024
• Last Updated: July 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)