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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2022-11-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1 (Traditional → Digital)

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.

Group Type EXPERIMENTAL

Dietary intervention for healthy weight loss

Intervention Type 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 2 (Digital → Traditional)

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)

Group Type EXPERIMENTAL

Dietary intervention for healthy weight loss

Intervention Type 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 3 - Young healthy population

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 4 - Senior population

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 5 - Oncological population

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 6 - COVID-19 population

(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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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:

* 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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes