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

NCT05807243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-04-11

No results posted yet for this study

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

Interventions

OTHER

Dietary intervention for healthy weight loss

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.

Sponsors & Collaborators

  • IMDEA Food

    lead OTHER

Principal Investigators

  • Ana Ramírez de Molina, PhD · Fundación IMDEA Alimentación

  • Enrique Carrillo de Santa Pau, PhD · Fundación IMDEA Alimentación

  • María Isabel Espinosa Salinas, PhD · Fundación IMDEA Alimentación

  • Cristina María Fernández Díaz, PhD · Fundación IMDEA Alimentación

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2022-06-23
Completion
2022-11-18

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05807243 on ClinicalTrials.gov