The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- change in quality of life
研究概览
简要总结
Lipedema is a female progressive fat disorder, characterized by a symmetrical increase in subcutaneous adipose tissue in the lower extremities with the exception of the waist. The condition is often misdiagnosed and underdiagnosed. The etiology is poorly understood. Affects about 11% of all women and may lead to pain and immobility. The pathophysiology may be related to sex hormones and inflammatory response. Lipedema fat has been reported not to respond to lifestyle changes or bariatric surgery, both in terms of weight loss and symptom reduction; including pain and quality of life. Clinical research on the effect of dietary interventions on lipedema does not exist, but a pilot study with a ketogenic diet showed a significant reduction in pain regardless of weight loss. The aim of the research project will be to investigate whether a ketogenic diet can be a treatment option for patients with lipedema. Therefore, a randomized controlled trial will be conducted to compare the effects of two diets. 1) energy-restricted ketogenic diet and 3) energy-restricted low-fat non-ketogenic diet for 8 weeks. Pain and quality of life will be mesured at start and immediately after the intervention. The hypothesis is that a ketogenic diet may reduce pain and improve quality of life.
详细描述
Study design RCT comparing a low-energy ketogenic diet to a non-ketogenic low-energy diet (non-keto) in females with lipedema. This study was approved by the Reginal Ethical Committee (REK 93888) All participants have to provided written informed consent in line with the Helsinki Declaration, before entering the study. Participants will be randomized by block randomization with stratification by BMI categories.
Study population Females diagnosed with lipedema, aged 18-75 years old, and a BMI between 30-45 kg/m2, will be invited to participate in this study. Participants had to be diagnosed with lipedema by physiotherapists before inclusion. Inclusion criteria includs weight stability for the last three months (±3 kg).
Dietary interventions Diets were matched for energy (1200 kcal/day) and protein, but differed in carbohydrate (CHO) and fat content.
The dietary plans are adjusted with respect to food preferences, intolerances, and allergies. The participants will be asked not to change their physical activity levels throughout the study period.
Compliance Participants will have weekly follow-ups. Participants will be asked to fill out daily food records throughout the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with lipedema by skilled physical therapists
- •Body mass index > 30kg/m2 and < 45kg/m2
- •Stable weight over the last three months (+2-3kg)
- •Not currently dieting to lose weight
- •Willing to meet for follow-ups every second week during the intervention
- •Willing to sign an informed consent before entering the study
排除标准
- •Pregnant or breast feeding
- •History of infectious diseases
- •Medication known to affect obesity
- •Enrolled in any other obesity treatment
- •Having had bariatric surgery.
- •Kidney disease is excluded
- •History of psychological disorders
- •Not mastering a Scandinavian language
- •Being mentally disabled
- •Malign disease
- •Any disease that leads to dietary advice that is not consistent with intervention advice
研究组 & 干预措施
Ketogenic low energy diet
Ketogenic low energy diet for 8 weeks
干预措施: Ketogenic low energy diet (Other)
non-Ketogenic low energy diet
non-Ketogenic low energy diet for 8 weeks
干预措施: non-ketogenic low energy diet (Other)
结局指标
主要结局
change in quality of life
时间窗: 8 weeks
Likert Scale
change in pain intensity
时间窗: 8 weeks
A difference in mean pain score of 2 units on a continuous scale from 0 to 10 on a visual analog scale (VAS) is considered clinically interesting
次要结局
未报告次要终点