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

NCT05807243 | Completed

• 1 other identifier: IMD: PI-052
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

Artificial Intelligence; Multi-modal learning; Nutrition; Biomarkers; Precision Nutrition; Immunosenescence

Outcome Measures

Primary Outcomes (4)

• BMI

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

  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.

  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)

  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.

  12 months

Secondary Outcomes (30)

• Weight

  1 month

• WC

  1 month

• Body composition

  1 month

• Blood pressure

  1 month

• Heart Rate

  1 month

Study Arms (6)

Group 1 (Traditional → Digital)

EXPERIMENTAL

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.

Other: Dietary intervention for healthy weight loss

Group 2 (Digital → Traditional)

EXPERIMENTAL

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)

Other: Dietary intervention for healthy weight loss

Group 3 - Young healthy population

NO INTERVENTION

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

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

(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

(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.

Interventions

Dietary intervention for healthy weight loss OTHER

Balanced and varied dietary plan adjusted to each participant's needs, with an approximate reduction of 500 Kcal from their total metabolic expenditure. The diet will be followed by the subjects during the 4 weeks of the study.

Group 1 (Traditional → Digital); Group 2 (Digital → Traditional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

IMDEA Food

Madrid, 28049, Spain

Location

Related Publications (4)

• 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.

  PMID: 25815989 BACKGROUND

• 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.

  PMID: 30954305 BACKGROUND

• 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.

  PMID: 32468984 BACKGROUND

• Lacruz-Pleguezuelos B, Bazan GX, Romero-Tapiador S, Freixer G, Tolosana R, Daza R, Fernandez-Diaz CM, Molina S, Crespo MC, Laguna T, Marcos-Zambrano LJ, Aguilar-Aguilar E, Fernandez-Cabezas J, Cruz-Gil S, Fernandez LP, Vera-Rodriguez R, Fierrez J, Ramirez de Molina A, Ortega-Garcia J, Morales A, Carrillo de Santa Pau E, Espinosa-Salinas I. AI4Food, a feasibility study for the implementation of automated devices in the nutritional advice and follow up within a weight loss intervention. Clin Nutr. 2025 May;48:80-89. doi: 10.1016/j.clnu.2025.03.003. Epub 2025 Mar 11.

  PMID: 40168934 DERIVED

Related Links

• Research team profile
• Research team profile
• Research team profile

MeSH Terms

Conditions

Chronic Disease

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Ana Ramírez de Molina, PhD

  Fundación IMDEA Alimentación

  PRINCIPAL INVESTIGATOR

• Enrique Carrillo de Santa Pau, PhD

  Fundación IMDEA Alimentación

  PRINCIPAL INVESTIGATOR

• María Isabel Espinosa Salinas, PhD

  Fundación IMDEA Alimentación

  PRINCIPAL INVESTIGATOR

• Cristina María Fernández Díaz, PhD

  Fundación IMDEA Alimentación

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 11, 2023
• Study Start: May 9, 2022
• Primary Completion: June 23, 2022
• Study Completion: November 18, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)