Description of Immunosenescence Biomarkers and Nutritional Intervention to Evaluate the Implementation of Digital Tools

IMDEA Food500 enrolled

Overview

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.

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.

Study Type

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria (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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

BMI

Only in the obese/overweight population. Change in body mass index (Kg/m2)

Time frame: 1 month

Blood Glucose

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.

Time frame: 1 month

Concentration of interstitial glucose

Only in the obese/overweight population. Change in Interstitial Glucose (mgl/dl) measured continuously with the Freestyle glucometer (Abbott Laboratories)

Time frame: 15 days

Blood lymphocytes

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.

Time frame: 12 months

Secondary Outcomes

Weight

Weight change (Kg)

Time frame: 1 month

Change in waist circumference (cm)

Time frame: 1 month

Body composition

Change in % of fat mass

Time frame: 1 month

Blood pressure

During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured in the study visits with an automatic Digital Blood Pressure Monitor Model M3 (OMRON HEALTHCARE UK, Kyoto, Japan). And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.

Time frame: 1 month

Heart Rate

Time frame: 1 month

Dietary intake

Traditional data-collection method: Two 3-day dietary records (for two working days and a holiday); Digital data-collection method: Pictures of food taken with a smartphone.

Time frame: 1 month

Physical activity

One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method: During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated International Physical Activity Questionnaire (USA Spanish version translated 3/2003 - Short last 7 DAYS self-administered version of the IPAQ - Revised August 2002). And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.

Time frame: 1 month

Sleep

One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method: During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated Oviedo Sleep Questionnaire. In the Oviedo Sleep Questionnaire, the higher the score, the greater insomnia's severity. And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.

Time frame: 1 month

Mental health state

One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method: During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated Depression Anxiety and Stress Scale - 21 (DASS-21). In the Depression Anxiety and Stress Scale, the higher the score, the greater the stress, anxiety and depression levels. And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.

Time frame: 1 month

Cognition

Measured via the validated Mini-mental state examination (MMSE). In the Mini-mental state examination, the higher the score, the better the cognitive status.

Time frame: 1 month

Health status and quality of life

Measured via the validated Short Form-36 Health Survey (SF-36). In the Short Form-36 Health Survey, the higher the score, the better the quality of life and health status.

Time frame: 1 month

Percentage of glycated haemoglobin

During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be only measured in the study visits with the blood tests. And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured continuously with the Freestyle glucometer (Abbott Laboratories), and in the study visits with the blood tests.

Time frame: 1 month

Total cholesterol