Impact of Ketone Bodies and Epigallocatechin Gallate in Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lipid peroxidation Malondialdehyde (MDA)
研究概览
简要总结
Based on the fact that the fundamental pathogenic mechanism of the Multiple Sclerosis (MS) disease is neuroinflammation, related in turn to cellular oxidation and mitochondrial alterations, this project aims to assess the impact of a nutritional intervention on the evolution of MS patients in their different slopes. To this end, the administration of medium-chain triglycerides, whose metabolism produces the increase of ketone bodies in the blood, will be carried out; and another of the antioxidant polyphenol epigallocatechin gallate. This procedure will be applied over 6 months, based on a isocaloric Mediterranean diet, with a population for the study of 80 patients with different variants of the disease. The assessment of the intervention will be carried out every two months, at motor-functional, anthropometric, cognitive and emotional, inflammatory, and oxidation levels.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Sclerosis patients older than 19 years ans under 65 who sign informed consent of the study
排除标准
- •Patients with coconut oil intolerance or other chronic metabolic pathologies
研究组 & 干预措施
Control Multiple Sclerosis
干预措施: Placebo (Other)
Intervention Multiple Sclerosis
干预措施: Coconut oil and epigallocatechin gallate (Dietary Supplement)
结局指标
主要结局
Lipid peroxidation Malondialdehyde (MDA)
时间窗: 0-4 months
Malondialdehyde (MDA) will be used as perioxidation marker. It is based on the reaction of thiobarbituric with malondialdehyde, product of the splitting of hydroperoxides, thus forming a color that can be measured directly. Its analysis is used for its good practicability and simplicity, but it lacks sensitivity, so it is recommended, to increase it, to use fluorometric or chromatographic procedures.
Interleukin 6 (IL-6)
时间窗: 0-4 months
Plasma concentrations of inflammatory markers (IL-6 and TNF-a) were determined by using a multiplex ELISA (Human ProInflammatory II 4-Plex Ultra-Sensitive Kit; Meso Scale Diagnostics).
Tumor necrosis factor alfa (TNF-alpha)
时间窗: 0-4 months
Plasma concentrations of inflammatory markers (IL-6 and TNF-a) were determined by using a multiplex ELISA (Human ProInflammatory II 4-Plex Ultra-Sensitive Kit; Meso Scale Diagnostics).
次要结局
- C-reactive protein(0-4 months)
- Quantitative electroencephalogram (QEEG)(0-4 months)
- Depression(0-4 months)
- Satiety(0-4 months)
- Skinfold calipe(0-4 months)
- Betahydroxybutyrate(0-4 months)
- Field oxide (FOX)(0-4 months)
- Total antioxidants (TEAC)(0-4 months)
- Anxiety(0-4 months)
- Paraoxonase 1 (PON1)(0-4 months)
- Hand Grip Strength(0-4 months)
- Muscle power(0-4 months)
- Haptoglobin(0-4 months)
- Copper reduction capacity (CUPRAC)(0-4 months)
- Iron reduction capacity (FRAP)(0-4 months)
- Sociodemographic(0 months)
- Body diameters(0-4 months)
- Body perimeters(0-4 months)
- Weight(0-4 months)
- Berg(0-4 months)
- Exercise tolerance(0-4 months)
- Physical function and symptoms(0-4 months)
- Neurological impairment(0-4 months)
- Manual dexterity(0-4 months)
- Muscle Strength Assessment Dynamometer (NEDDFM/IBV )(0-4 months)
- Height(0-4 months)
- Gait speed(0-4 months)
研究者
José Enrique de la Rubia Ortí
Director
Fundación Universidad Católica de Valencia San Vicente Mártir