Ketone Bodies and Gut Microbiota Role in the Dietetic Approach of Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Changes in gut microbiota composition
研究概览
简要总结
Main aim: Study the anthropometric, metabolic, cardiovascular and neurocognitive and gut microbiota changes of different approaches for the weight reduction that increase the ketone bodies in a different proportion in relation to the classic hypocaloric diet.
Objective 1: Study the effect of hypocaloric diets that increase the ketone bodies on gut microbiota and its relationship with anthropometric changes and of the Brown adipose tissue, Objective 2: with the metabolic and inflammatory changes, Objective 3: on the cardiovascular system, Objective 4: on the neurocognition, Objective 5: if they are associated to epigenetic changes that may explain the changes found in the other objectives. Objective 6: Determine the safety of the diets that increase the ketone bodies compared to the classic hypocaloric diet, Objective 7: if the effects of the different dietary approaches are maintained during the medium time, and Objective 8: Verify in experimental models (microbiota transplants from humans with different diets to germ-free mice, ketosis dietary models, and ketone bodies administration) the causality of the gut microbiota of these findings.
Methodology: Model 1: Dietary intervention in humans with 4 types of diet with a different increase of the ketone bodies: classic hypocaloric diet (DH); diet with 8h of feeding and 16h of starving in periods of 24h (D16); diet with intermittent caloric restriction (DA); and normal in protein and low in carbohydrates hypocaloric ketogenic diet (DC).
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
- 是
入选标准
- •Obesity (BMI≥30-45 kg/m2)
排除标准
- •Type 2 diabetes mellitus
- •Patients with major cardiovascular events in the 6 months prior to the study beginning.
- •Previous or current history of inflammatory disease.
- •Active infectious disease.
- •The refusal of the patient to participate in the study
- •Consumption of probiotics or prebiotics
- •Antibiotic therapy in the 3 months prior to the study
结局指标
主要结局
Changes in gut microbiota composition
时间窗: Baseline, 12 weeks
To evaluate changes in gut microbiota composition from baseline using different strategies for weight loss which increase ketone bodies in comparison to a standard hypocaloric diet. Change from baseline in 16S rRNA amplicons of fecal community DNA at 3 months and 6 months
次要结局
- Changes in body composition.(Baseline, 12 weeks)
- Changes in uncoupling protein 1 (UCP1)(Baseline, 12 weeks)
- Changes in blood pressure(Baseline, 12 weeks)
- Changes in heart rate(Baseline, 12 weeks)
- Changes in weight(Baseline, 12 weeks)
- Changes in brown adipose tissue.(Baseline, 12 weeks)
- Changes in the punctuation in neurocognitive test(Baseline, 12 weeks)
- Changes in body mass index.(Baseline, 12 weeks)
- Changes in waist circumference.(Baseline, 12 weeks)
- Changes in physical activity.(Baseline, 12 weeks)