Effect of a Low-Carbohydrate, High-Fat (LCHF) Ketogenic Diet on Adipose Tissue Hormones, Oxidative Stress, Inflammation, Lymphatic and Angiogenic Factors, Metabolomics, Symptoms, and Quality of Life in Women With Lipedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Change in leg circumferences
研究概览
简要总结
Lipedema is a chronic fat tissue disorder that usually affects the lower limbs, excluding the feet. Clinical symptoms of lipedema include a noticeable disproportion between the upper and lower body, a tendency to easy bruising, and pain in the fatty tissue. It is a common disorder that occurs almost exclusively in women, potentially affecting around 11% of the adult population worldwide. The disease, especially in its advanced stages, has negative psychosocial consequences, leading to social isolation or depression, among other issues. The etiology of the disease is unknown, but genetic, hormonal, and inflammatory factors are likely involved in its pathogenesis. This disorder is characterized by the presence of low-grade inflammation in the fat tissue. The use of reduction diets combined with physical activity or bariatric surgery does not constitute an effective therapeutic approach for lipedema. Recent interventional studies show that an anti-inflammatory ketogenic diet leads to a reduction in leg volume and lipedema symptoms, including pain in the extremities.
This study aims to evaluate clinical, metabolic, inflammatory, and vascular characteristics in women with lipedema and to assess potential changes associated with dietary intervention - 7 months of ketogenic diet (low carbohydrate, high fat).
Participants undergo clinical, laboratory, and patient-reported outcome assessments to evaluate anthropometric parameters, quality of life, and selected biomarkers. The findings are expected to improve understanding of the biological mechanisms underlying lipedema and to support the development of targeted therapeutic strategies.
详细描述
A total of 121 women were invited to participate in the study. The study group consisted of patients from the Angiology Outpatient Clinic at Wroclaw Medical University in Poland with the diagnosis of lipedema made by an angiologist (n=66). The control volunteer group was composed of women with overweight or obesity (body mass index, BMI= 25 kg/m2) who were not affected by lipedema (n=55).
All participants recruited to the study underwent following procedures at the beginning and at the end of the study:
- Measurement of anthropometric parameters:
- height - A TANITA HR-001 growth meter (Tanita, Tokyo, Japan)
- weight and body composition parameters (body fat, lean body mass, body water, visceral fat) - A TANITA MC-780MA (Tanita, Tokyo, Japan)
- waist, hip and leg circumferences (at 4 cm intervals from the ankle to the groin on the side of the leg) - standard tape measure to the nearest 1 cm
- Questionnaires:
- assessment of pain level in the leg - visual analogue scale (VAS)
- assessment of psychological status, symptoms and quality of life:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •consent to participate in the study
- •diagnosis of lipedema proved by an angiologist
- •overweight or obesity based on BMI>25 kg/m2
排除标准
- •pregnancy and period of 6 months after pregnancy,
- •breastfeeding,
- •diagnosis of lymphedema,
- •edema in the course of chronic vein insufficiency or heart failure,
- •diabetes mellitus,
- •kidney or liver failure,
- •hormonally unbalanced thyroid disease,
- •implanted cardiac devices (cardiac pacemaker, implantable cardioverter-defibrillator, resynchronization therapy)
- •metal implants
研究组 & 干预措施
Patients with lipedema (interventional group)
Patients with diagnosis of lipedema who following the interventional (ketogenic) diet.
干预措施: Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties (Behavioral)
Patients with overweight/obesity (control group)
Patients with overweight/obesity (BMI > 25 kg/m2) without lipedema symptoms who following the interventional (ketogenic) diet.
干预措施: Low carbohydrate high fat (ketogenic) diet with anti-inflammatory properties (Behavioral)
结局指标
主要结局
Change in leg circumferences
时间窗: Up to 7 months
Changes in leg circumferences between 2 timepoints (baseline and end of study)
次要结局
- Change in body weight(Up to 7 months)
- Change in body fat(Up to 7 months)
- Change in lean body mass(Up to 7 months)
- Change in body water(Up to 7 months)
- Change in visceral fat level(Up to 7 months)
- Change in disability level(Up to 7 months)
- Change in depressive symptoms(Up to 7 months)
- Change in anxiety and depression symptoms(Up to 7 months)
- Change in lower extremity symptoms(Up to 7 months)
- Change in psychological distress(Up to 7 months)
- Change in quality of life(Up to 7 months)
- Change in pain intensity in the legs(Up to 7 months)
- Change in leptin concentration(Up to 7 months)
- Change in adiponectin concentration(Up to 7 months)
- Change in resistin concentration(Up to 7 months)
- Change in vaspin concentration(Up to 7 months)
- Change in visfatin concentration(Up to 7 months)
- Change in TNF-α concentration(Up to 7 months)
- Change in IL-1β concentration(Up to 7 months)
- Change in IL-8 concentration(Up to 7 months)
- Change in IL-10 concentration(Up to 7 months)
- Change in IL-13 concentration(Up to 7 months)
- Change in CRP concentration(Up to 7 months)
- Change in TBARS concentration(Up to 7 months)
- Change in 8-iso-prostaglandin F2α concentration(Up to 7 months)
- Change in protein carbonyl content(Up to 7 months)
- Change in total antioxidant capacity(Up to 7 months)
- Change in SOD activity(Up to 7 months)
- Change in CAT activity(Up to 7 months)
- Change in vitamin C concentration(Up to months)
- Change in vitamin A concentration(Up to 7 months)
- Change in vitamin E concentration(Up to 7 months)
- Change in VEGF-A concentration(Up to 7 months)
- Change in VEGF-C concentration(Up to 7 months)
- Change in VEGF-D concentration(Up to months)
- Change in angiopoietin-2 concentration(Up to 7 months)
- Change in sICAM-1 concentration(Up to 7 months)
- Change in sVCAM-1 concentration(Up to 7 months)
- Change in P-selectin concentration(Up to 7 months)
- Change in eicosanoids concentrations(Up to 7 months)
- Change in endocannabinoids concentrations(Up to 7 months)
- Change in nitric oxide metabolites concentrations(Up to 7 months)