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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 20 partecipants with changes in blood count
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged > 18 years
- •With a diagnosis of lipedema (II - III clinical stage)
排除标准
- •Subjects without an indication for treatment
- •Subjects who cannot undergo VLCKD treatment
- •Pregnancy and lactation
- •Treatment with drugs that interfere with proper microbiota analysis
研究组 & 干预措施
Obese patients with lipedema
Obese patients with lipedema treated with vegan VLEKT
干预措施: Very Low Energy Ketogenic Therapy with vegan meal replacements (Dietary Supplement)
结局指标
主要结局
20 partecipants with changes in blood count
时间窗: From enrollment to the end of treatment at 45 days
20 partecipants with changes in blood glucose, total and HDL cholesterol, and triglycerides
时间窗: From enrollment to the end of treatment at 45 days
blood glucose (mg/dL), total and HDL cholesterol (mg/dL), and triglycerides (mg/dL)
20 partecipants with changes in c-reactive protein (CPR)
时间窗: From enrollment to the end of treatment at 45 days
CPR (mg/L)
20 partecipants with changes in erythrocyte sedimentation rate (ESR)
时间窗: From enrollment to the end of treatment at 45 days
ESR (mm/h)
20 partecipants with changes in insulin
时间窗: From enrollment to the end of treatment at 45 days
insulin (µU/mL)
20 partecipants with changes in HOMA-INDEX
时间窗: From enrollment to the end of treatment at 45 days
HOMA-INDEX (threshold of 2.5)
20 partecipants with changes in body water (Total Body Water, Extracellular Water, Intracellular Water) by means of bioimpedance analysis (Akern BIVA 101)
时间窗: From enrollment to the end of treatment at 45 days
Total Body Water (L), Extracellular Water (L), Intracellular Water (L)
20 partecipants with changes in Free Fat Mass, Fat Mass, Body Cell Mass by means of bioimpedance analysis (Akern BIVA 101)
时间窗: From enrollment to the end of treatment at 45 days
Free Fat Mass (Kg), Fat Mass (Kg), Body Cell Mass (Kg)
20 partecipants with changes in Skeletal Muscle Index by means of bioimpedance analysis (Akern BIVA 101)
时间窗: 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)
Short form of the McGill Pain Questionnaire (SF-MPQ)
时间窗: 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.
EuroQoL 5D (EQ-5D)
时间窗: 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.
20 partecipants with changes in weight
时间窗: From enrollment to the end of treatment at 45 days
weight (kg)
20 partecipants with changes in BMI
时间窗: 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);
20 partecipants with changes in circumferences
时间窗: 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).
20 partecipants with changes in blood count
时间窗: From enrollment to the end of treatment at 45 days
20 partecipants with changes in blood glucose, total and HDL cholesterol, and triglycerides
时间窗: From enrollment to the end of treatment at 45 days
blood glucose (mg/dL), total and HDL cholesterol (mg/dL), and triglycerides (mg/dL)
20 partecipants with changes in c-reactive protein (CPR)
时间窗: From enrollment to the end of treatment at 45 days
CPR (mg/L)
20 partecipants with changes in erythrocyte sedimentation rate (ESR)
时间窗: From enrollment to the end of treatment at 45 days
ESR (mm/h)
20 partecipants with changes in insulin
时间窗: From enrollment to the end of treatment at 45 days
insulin (µU/mL)
20 partecipants with changes in HOMA-INDEX
时间窗: From enrollment to the end of treatment at 45 days
HOMA-INDEX (threshold of 2.5)
20 partecipants with changes in body water (Total Body Water, Extracellular Water, Intracellular Water) by means of bioimpedance analysis (Akern BIVA 101)
时间窗: From enrollment to the end of treatment at 45 days
Total Body Water (L), Extracellular Water (L), Intracellular Water (L)
20 partecipants with changes in Free Fat Mass, Fat Mass, Body Cell Mass by means of bioimpedance analysis (Akern BIVA 101)
时间窗: From enrollment to the end of treatment at 45 days
Free Fat Mass (Kg), Fat Mass (Kg), Body Cell Mass (Kg)
20 partecipants with changes in Skeletal Muscle Index by means of bioimpedance analysis (Akern BIVA 101)
时间窗: 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)
Short form of the McGill Pain Questionnaire (SF-MPQ)
时间窗: 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.
EuroQoL 5D (EQ-5D)
时间窗: 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.
次要结局
未报告次要终点
研究者
Lucio Gnessi
Clinical Professor
University of Roma La Sapienza