Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
研究概览
简要总结
The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Obesity has a strong impact not only on the metabolism of the patients, but also may impact hormonal, inflammatory and immune profile, and profoundly influence the daily life of the patients. Weight loss may determine an amelioration of these parameters, but the impact of the diet composition aimed to weight loss on them has not been profoundly studied yet.
The aim of our research project is to study the effects of a ketogenic diet in comparison with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and immunological parameters in obese patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •BMI≥ 30 Kg/m2
排除标准
- •Type 1 diabetes mellitus and latent autoimmune diabetes in adults
- •β-cell failure in type 2 diabetes mellitus
- •Use of sodium/glucose cotransporter 2 (SGLT2) inhibitors
- •Pregnancy and breastfeeding
- •Kidney failure and moderate-to-severe chronic kidney disease
- •Liver failure
- •Heart failure (NYHA III-IV)
- •Respiratory failure
- •Unstable angina, stroke or myocardial infarction in the last 12 months
- •Cardiac arrhythmias
- •Eating disorders and other severe mental illnesses, alcohol and substance abuse
- •Active/severe infections
- •Planned elective surgery or invasive procedures
- •Rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency
结局指标
主要结局
Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
时间窗: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment with the questionnaires Short Form Health Survey 36 (SF-36); scale of every item from 0 to 100; the higher the score, the better the quality of life
Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires
时间窗: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment with the questionnaires Impact of weight/Quality of Life-Lite (IWQOL-Lite); global scale from 0 to 100; the higher the score, the better the quality of life
Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires
时间窗: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem
次要结局
- Evaluation of changes in inflammation(At baseline, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in sleep parameters (length)(At baseline, at 30 days)
- Evaluation of changes in hip circumference(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in waist circumference(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Change in circadian rhythm(At baseline, at 30 days)
- Evaluation of changes in Sexual Function in Females(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in sleep efficiency(At baseline, at 30 days)
- Evaluation of changes in number of awakenings(At baseline, at 30 days)
- Evaluation of changes in sleep parameters(At baseline, at 30 days)
- Evaluation of changes in metabolic parameters(At baseline, at 30 days)
- Evaluation of changes in BMI(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of weight loss(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes of perceived sleep(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes of perceived sleepiness(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in clock genes expression(At baseline, at 30 days)
- Evaluation of changes in hormonal profile(At baseline, at 30 days)
- Evaluation of changes in sexual function in males(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of weight loss(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes of perceived sleep(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes of peripheral blood mononuclear cells(At baseline, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes of perceived sleepiness(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in sleep efficiency(At baseline, at 30 days)
- Evaluation of height(At baseline)
- Evaluation of changes in whole blood cells gene expression(At baseline, at 30 days)
- Evaluation of changes in clock genes expression(At baseline, at 30 days)
- Evaluation of changes in sexual function in males(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in number of awakenings(At baseline, at 30 days)
- Evaluation of changes in hormonal profile(At baseline, at 30 days)
- Evaluation of changes in inflammation(At baseline, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in sleep parameters (length)(At baseline, at 30 days)
- Evaluation of changes in hip circumference(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in waist circumference(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in sleep parameters(At baseline, at 30 days)
- Change in circadian rhythm(At baseline, at 30 days)
- Evaluation of changes in Sexual Function in Females(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in metabolic parameters(At baseline, at 30 days)
- Evaluation of changes in BMI(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
研究者
Lucio Gnessi
Full Professor
University of Roma La Sapienza