Pilot Study: Ketogenic Diet as Protective Factor During SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The total hospital stay
研究概览
简要总结
The novel coronavirus disease (COVID-19) is posing a serious challenge to the health-care systems worldwide, with an enormous impact on health conditions and loss of lives. More than 30 millions of recoveries worldwide were registered at the end of October 2020 with more than 1 million of deaths. As the disease continues to spread, strategies aimed to reduce hospitalization time in sub intensive unit care, thus reducing pressure on health system, but also to reduce some of the pathological features of COVID-19 such as inflammation and the "cytokines storm".
The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes a physiological ketosis (due to an increase of liver ketone bodies production). High fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. Moreover, the physiological increase in plasma levels of ketone bodies exerts important anti-inflammatory and immunomodulating effects, which may reveal as precious tools to reduce potential adverse outcomes of COVID-19 disease.
The hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and the duration of hospitalization. The plan is to enrol 28 patients with diagnosis of COVID-19 hospitalized but not in ICU with SPO2 higher than 88%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized Hospital with COVID-19 diagnosis (nasopharyngeal and oropharyngeal swab)
- •peripheral oxygen saturation higher tha 88%
排除标准
- •intensive unit care
- •under forced ventilation
- •peripheral oxygen saturation lower than 88%
- •parenteral nutrition
研究组 & 干预措施
Intervention
Patients will receive 21 days of a very low carbohydrate mediterranean ketogenic diet with phytoextracts and 7 days of a low carbohydrate diet
干预措施: Ketogenic diet with phytoextracts (Dietary Supplement)
结局指标
主要结局
The total hospital stay
时间窗: up to 30 days
Time from hospital admission to discharge from the hospital.
inflammation panel: tumor necrosis factor alfa (TNFα)
时间窗: Daily untilpatient's hospital discharge, up to 30 days
change in TNFα levels. TNFα is an inflammatory cytokine Units: pg/mL
inflammation panel: C-reactive Protein (CRP)
时间窗: Daily until patient's hospital discharge, up to 30 days
change in CRP levels. CRP is an non specific index of inflammation Units: in mg/dL
inflammation panel: Erythrocyte sedimentation rate (ESR)
时间窗: Daily untilpatient's hospital discharge, up to 30 days
change in ESR. ESR is an non specific index of inflammationUnits: mm/h
coagulation panel: fibrinogen
时间窗: Daily until patient's hospital discharge, up to 30 days
change in fibrinogen levels. Fibrinogen is a protein involved in forming blood clots in the body. Units: mg/dL
coagulation panel: thrombin clotting time (TT)
时间窗: Daily until patient's hospital discharge, up to 30 days
change in TT. TT measures the time it takes for a clot to form in the plasma of a blood sample containing anticoagulant, after an excess of thrombin has been added. Units: seconds
coagulation panel: activated partial thromboplastin time (aPTT)
时间窗: Daily until patient's hospital discharge, up to 30 days
change inl aPTT. aPTT measures the overall speed at which blood clots by means of two consecutive series of biochemical reactions. Units: in seconds
inflammation panel: interleukine 6 (IL-6)
时间窗: Daily until patient's hospital discharge, up to 30 days
change in IL-6 levels. IL-6 is an inflammatory cytokine. Units: in pg/mL
coagulation panel: D-Dimer
时间窗: Daily until patient's hospital discharge, up to 30 days
change in D-Dimer levels. D-Dimer is a fibrin degradation product. Units: 0.5 mcg/ml Fibrinogen Equivalent Units (FEU)
Dyspnoea Visual Analog Scale Score (VAS)
时间窗: Daily until patient's hospital discharge, up to 30 days
Change in VAS. VAS is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The VAS dyspnea score uses "no shortness of breath at all" and "maximum shortness of breath". The patient marks on the line the point that they feel represents the perception of their current state
Evaluation of Lungs conditions
时间窗: Change from baseline, Every three days until patient's hospital discharge, up to 30 days
Anteroposterior chest radiography (CXR)
Oxygen saturation
时间窗: Continuosly, daily until patient's hospital discharge, up to 30 days
change in basal peripheral oxygen saturation percentage (%)
次要结局
- Red blood cells count(Daily until patient's hospital discharge, up to 30 days)
- Alanine transaminase (ALT)(Daily until patient's hospital discharge, up to 30 days)
- Aspartate transaminase (AST)(Daily until patient's hospital discharge, up to 30 days)
- Mean Corpuscular Hemoglobin (MCH)(Daily until patient's hospital discharge, up to 30 days)
- Mean corpuscular volume (MCV)(Daily until patient's hospital discharge, up to 30 days)
- mean corpuscular hemoglobin concentration (MCHC)(Daily until patient's hospital discharge, up to 30 days)
- beta - hydroxybutyrate (BHB)(Daily until patient's hospital discharge, up to 30 days)
- lactate dehydrogenase (LDH)(Daily until patient's hospital discharge, up to 30 days)
- haemoglobin Hb(Daily until patient's hospital discharge, up to 30 days)
研究者
Antonio Paoli
Full Professor
University of Padova