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

IMDEA Food

Status: Completed

Conditions: Chronic Disease

Treatments: Other: Dietary intervention for healthy weight loss

Study type: Interventional

Funder types: Other

Identifiers

NCT05807243

IMD: PI-052

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

500 participants in 6 patient groups

Group 1 (Traditional → Digital)

Experimental group

Description:

Participants in both groups will be monitored for a month while following an hypocaloric diet for healthy weight-loss. The first group (n=50) will start collecting data via questionnaires (traditional method) for the first two weeks, and switch to the digital data-collection method for the last two weeks.

Treatment:

Other: Dietary intervention for healthy weight loss

Group 2 (Digital → Traditional)

Experimental group

Description:

Participants in both groups will be monitored for a month while following an hypocaloric diet for healthy weight-loss. The second group (n=50) will start with the digital data-collection method for the first two weeks and switch to the data collection via questionnaires (traditional method) for the last two weeks. n=100)

Treatment:

Other: Dietary intervention for healthy weight loss

Group 3 - Young healthy population

No Intervention group

Description:

n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.

Group 4 - Senior population

No Intervention group

Description:

n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.

Group 5 - Oncological population

No Intervention group

Description:

(n=100) Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.

Group 6 - COVID-19 population

No Intervention group

Description:

(n=100) patients who developed severe forms of COVID-19 or persistent COVID-19. Descriptive part: Data capture (clinical, anthropometric, lifestyle, genetic, biochemical, metabolomic and lipidomic data, among others) and comparison with the other groups.