Descriptive Study of Molecular Markers of Immunosenescence With Nutritional Intervention to Evaluate the Implementation of Digital Tools in the Capture of Nutritional Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Concentration of interstitial glucose
研究概览
简要总结
Descriptive comparative study of immunosenescence markers and their association with nutritional, metabolic, metabolomic and genetic characteristics in young (control), senior (age-associated immunosenescence), and populations susceptible to premature immunosenescence such as obese patients, cancer patients and patients who developed severe forms of COVID19 or persistent COVID19.
In one of these populations of premature immunosenescence, the population group with overweight or obesity, a prospective and cross-sectional nutritional intervention study is proposed, with data capture and monitoring using digital tools, to evaluate the evolution of immunosenescence markers and assess more objectively and effectively the nutritional status and help in making personalised decisions thanks to the application of these tools. This nutritional intervention will be focused on controlled and safe weight loss that will allow the capture of a large number of variables on lifestyle and dietary habits, nutritional assessment, biochemical, metabolic, genetic, metagenomic, lipidomic and metabolomic markers measured statically and also continuously.
详细描述
The study consists of data capturing to evaluate the differential pattern of molecular markers of immunosenescence in different population groups, and applying a hypocaloric diet in the obesity subgroup together with recommendations for improving lifestyle habits. The data capture of this group during the intervention will be carried out with different sensors and questionnaires for a month. To do this, they will have to follow the explanations of the researchers.
The data capture during the nutritional intervention (only for the overweight and obese population group) will be done as follows:
Group 1 (Traditional → Digital): will start with traditional data-collection methods, i.e. filling in nutritional and lifestyle questionnaires (Visit 1 to Visit 2). After two weeks, they will start capturing data digitally through the application of sensors (Visit 2 to Visit 3).
Group 2 (Digital → Traditional): will start with digital data-collection methods, using sensors and taking pictures of what they eat with a smartphone (Visit 1 to Visit 2). After two weeks, they will start capturing data traditionally, by filling in nutritional and lifestyle questionnaires (Visit 2 to Visit 3).
The nutritional intervention participant group will follow the tailored nutritional weight loss diet and lifestyle guidelines, which will be provided to them at the start of the study by the researchers. In addition, they should follow instructions for proper continuous data collection using sensors. This will avoid biases in the data collection process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(commun for all groups):
- •Men/women
- •Minimum 18 years old
- •Adequate cultural level and understanding of the clinical study.
- •Agree to participate voluntarily in the study and give written informed consent.
- •Population-specific inclusion criteria:
- •Overweight/obese population:
- •BMI 25-35 Kg/m2
- •Ability to handle electronic devices for data capture.
- •Healthy young population:
- •Between 18 and 25 years old (both inclusive).
- •Senior population
- •Over 55 years of age.
- •Oncology patients
- •Over 18 years of age.
- •With a clinical diagnosis of an active tumour process.
- •Patients who developed severe or persistent COVID-19:
- •Severe COVID-19: Patients who have suffered from COVID-19 disease and whose symptomatology is considered within the clinical pictures of severity of this disease, which may include: severe pneumonia, acute respiratory distress syndrome (ARDS), presence of respiratory failure (SaO2 <90% room air) or respiratory rate ≥ 30 breaths per minute, sepsis, septic shock, thromboembolism and multi-organ dysfunction (including acute cardiac and renal injuries).
- •COVID-19 persistence: Patients who have had COVID-19 disease and who remain with active symptomatology after what is considered the acute phase of the disease, after 4 or even 12 weeks, with symptoms persisting over time.
排除标准
- •Dementia, mental illness or diminished cognitive function that can hinder the subject's participation on the study.
- •Severe diseases (liver disease, kidney disease, etc.)
- •BMI > 35 Kg/m2
- •Pregnancy or breastfeeding.
- •Population-specific exclusion criteria:
- •Overweight/obese population:
- •BMI <25 Kg/m2 or > 35 Kg/m2
- •Pharmacological treatment for weight loss.
- •Refusal to be monitored for one month by means of sensors and nutritional visits.
- •Refusal to follow healthy eating guidelines for weight loss.
- •Healthy young population:
- •Chronic or acute pathologies.
结局指标
主要结局
Concentration of interstitial glucose
时间窗: 15 days
Only in the obese/overweight population. Change in Interstitial Glucose (mgl/dl) measured continuously with the Freestyle glucometer (Abbott Laboratories)
Blood lymphocytes
时间窗: 12 months
Variation in the percentage of blood lymphocytes analysed by flow cytometry in five different population groups (young healthy population, elderly, overweight-obese, cancer patients, and patients who developed severe forms of COVID-19 or persistent COVID-19). Other variables (described in the Secondary Outcomes), such as biochemical parameters, genetical data, microbiota, etc., will also be analyzed in order to identify specific molecular markers of immunosenescence.
BMI
时间窗: 1 month
Only in the obese/overweight population. Change in body mass index (Kg/m2)
Blood Glucose
时间窗: 1 month
Change in blood glucose (mg/dl). Blood samples are going to be collected in visit 1 and visit 3 in the obese population, and in the visit 1 in the other populations.
次要结局
- Weight(1 month)
- Heart Rate(1 month)
- Cognition(1 month)
- Physical activity(1 month)
- Adinopectin(1 month)
- Dietary intake(1 month)
- Mental health state(1 month)
- Percentage of glycated haemoglobin(1 month)
- Low density lipoprotein (LDL)(1 month)
- Apo B(1 month)
- Insulin(1 month)
- Homeostatic model assessment (HOMA)(1 month)
- Faecal microbiota(1 month)
- WC(1 month)
- Body composition(1 month)
- Sleep(1 month)
- Total cholesterol(1 month)
- High density lipoprotein (HDL)(1 month)
- Albumin(1 month)
- Leptin(1 month)
- Genotype(1 month)
- Blood pressure(1 month)
- Health status and quality of life(1 month)
- Triglycerides(1 month)
- Glycated hemoglobin (HbA1c)(1 month)
- C-reactive protein (CRP)(1 month)
- Gut dysbiosis(1 month)
- Apo A1(1 month)
- Prealbumin(1 month)
- Gene expression(1 month)