NCT05848544已完成不适用
Efficacy of a Very Low Calories Ketogenic Diet in Obese Patients With Fibromyalgia or Symptomatic Knee Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- efficacy of the very low-calorie ketogenic diet in patient with fibromyalgia
研究概览
简要总结
Adult patients with fibromyalgia or symptomatic knee osteoarthritis and comorbid obesity eligible to a very low calories ketogenic diet will be enrolled in the pilot study
详细描述
the study will be conducted following different periods:
- Free diet (for 4 weeks). After recruitment, the patient will enter "free diet phase" in which he/she will be asked to follow a normal free diet for 4 weeks. During this period, a nutritional interview will be carried out by a trained dietician who will elaborate a personalized diet and order the ketogenic products on the basis of patient's preferences.
- very low calories ketogenic diet (for 8 weeks). After the free diet period, the patient will start the very low calories ketogenic regimen. At the beginning of this period a box with the commercial products necessary to cover the whole study period will be hand-delivered by a dietician that will instruct the patient on the correct use and storage.
- Maintenance (for 12 weeks). After very low calories ketogenic diet phase, the patient will start maintenance period as described
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 65 years
- •Body mass index ≥ 30 kg/m2
- •Failed to achieve weight loss with standard low-calories diet
- •Any of the following conditions:
- •BMI ≥ 35 kg/m2 Past diagnosis of type 2 diabetes without β-cell failure Hypertriglyceridemia (fasting triglycerides ≥ 150 mg/dL) or taking lipid-lowering medications Hypercholesterolemia (total cholesterol > 200 mg/dL) or taking lipid-lowering medications Past diagnosis of arterial hypertension or taking blood pressure-lowering medications Past diagnosis of non-alcoholic fatty liver disease Past diagnosis of heart failure class NYHA I-II Past history of myocardial infarction (> 12 months), stroke/minor stroke (> 12 months) Past diagnosis of carotid atherosclerosis Past diagnosis of polycystic ovary syndrome (PCOS) Past diagnosis of neurodegenerative disorders
- •Fibromyalgia classified according to 2016 Revisions to the 2010/2011 European League Against Rheumatism/ American College of Rheumatology OR
- •Symptomatic knee osteoarthritis
排除标准
- •Age < 18 or > 65 years
- •Currently pregnant or breastfeeding
- •Past diagnosis of type 1 diabetes mellitus, latent autoimmune diabetes in adults, β-cell failure in type 2 diabetes mellitus, use of sodium/glucose cotransporter 2 inhibitors (risk for euglycemic diabetic ketoacidosis)
- •Past diagnosis of kidney failure and moderate-to-severe chronic kidney disease, liver failure, hearth failure NYHA III-IV, respiratory failure
- •Past diagnosis of unstable angina
- •Recent stroke or myocardial infarction (< 12 months)
- •Cardiac arrhythmias
- •Past diagnosis of eating disorders and other severe mental illnesses, alcohol and substance abuse
- •Active/severe infections
- •48 h prior to elective surgery or invasive procedures and perioperative period
- •Past diagnosis of rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency
- •Allergy to protein-preparations ingredients
- •Past or current history of gallstones
结局指标
主要结局
efficacy of the very low-calorie ketogenic diet in patient with fibromyalgia
时间窗: baseline, 8 weeks and 20 weeks
change in Fibromyalgia Impact Questionnaire total score for fibromyalgia
efficacy of the very low-calorie ketogenic diet in patient with osteoarthritis
时间窗: baseline, 8 weeks and 20 weeks
change in Western Ontario total score for osteoarthritis
次要结局
未报告次要终点
研究者
研究点 (2)
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