Descriptive Study of Molecular Markers of Immunosenescence With Nutritional Intervention to Evaluate the Implementation of Digital Tools in the Capture of Nutritional Data
Trial ID: NCT05807243
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-05-09
Completion date: 2022-11-18
Sponsor: IMDEA Food
Conditions: Chronic Disease
Interventions: Dietary intervention for healthy weight loss
Locations: IMDEA Food
Countries: Spain
Enrollment: 500
Age range: 18 Years - None
Sex: ALL

Summary:
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.

Eligibility 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.

Outcomes:
BMI; Blood Glucose; Concentration of interstitial glucose; Blood lymphocytes