Clinical trial NCT05807243: Description of Immunosenescence Biomarkers and Nutritional Intervention to Evaluate the Implementation of Digital Tools
Official title: Descriptive Study of Molecular Markers of Immunosenescence With Nutritional Intervention to Evaluate the Implementation of Digital Tools in the Capture of Nutritional Data
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Artificial Intelligence
Multi-modal learning
Nutrition
Biomarkers
Precision Nutrition
Immunosenescence
Lead sponsor: IMDEA Food
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: BMI
timeFrame: 1 month
measure: Blood Glucose
timeFrame: 1 month
measure: Concentration of interstitial glucose
timeFrame: 15 days
measure: Blood lymphocytes
timeFrame: 12 months
Secondary outcomes:
measure: Weight
timeFrame: 1 month
measure: WC
timeFrame: 1 month
measure: Body composition
timeFrame: 1 month
measure: Blood pressure
timeFrame: 1 month
measure: Heart Rate
timeFrame: 1 month
measure: Dietary intake
timeFrame: 1 month
measure: Physical activity
timeFrame: 1 month
measure: Sleep
timeFrame: 1 month
measure: Mental health state
timeFrame: 1 month
measure: Cognition
timeFrame: 1 month
measure: Health status and quality of life
timeFrame: 1 month
measure: Percentage of glycated haemoglobin
timeFrame: 1 month
measure: Total cholesterol
timeFrame: 1 month
measure: Low density lipoprotein (LDL)
timeFrame: 1 month
measure: High density lipoprotein (HDL)
timeFrame: 1 month
measure: Triglycerides
timeFrame: 1 month
measure: Apo A1
timeFrame: 1 month
measure: Apo B
timeFrame: 1 month
measure: Insulin
timeFrame: 1 month
measure: Glycated hemoglobin (HbA1c)
timeFrame: 1 month
measure: Homeostatic model assessment (HOMA)
timeFrame: 1 month
measure: Albumin
timeFrame: 1 month
measure: Prealbumin
timeFrame: 1 month
measure: C-reactive protein (CRP)
timeFrame: 1 month
measure: Leptin
timeFrame: 1 month
measure: Adinopectin
timeFrame: 1 month
measure: Faecal microbiota
timeFrame: 1 month
measure: Gut dysbiosis
timeFrame: 1 month
measure: Genotype
timeFrame: 1 month
measure: Gene expression
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IMDEA Food
Study officials:
affiliation: Fundación IMDEA Alimentación
name: Ana Ramírez de Molina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación IMDEA Alimentación
name: Enrique Carrillo de Santa Pau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación IMDEA Alimentación
name: María Isabel Espinosa Salinas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación IMDEA Alimentación
name: Cristina María Fernández Díaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fontana L, Partridge L. Promoting health and longevity through diet: from model organisms to humans. Cell. 2015 Mar 26;161(1):106-118. doi: 10.1016/j.cell.2015.02.020.
citation: GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.
citation: Moore JB. From personalised nutrition to precision medicine: the rise of consumer genomics and digital health. Proc Nutr Soc. 2020 Aug;79(3):300-310. doi: 10.1017/S0029665120006977. Epub 2020 May 29.