Description of Immunosenescence Biomarkers and Nutritional Intervention to Evaluate the Implementation of Digital Tools
- Conditions
- Chronic Disease
- Interventions
- Other: Dietary intervention for healthy weight loss
- Registration Number
- NCT05807243
- Lead Sponsor
- IMDEA Food
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1 (Traditional → Digital) Dietary intervention for healthy weight loss 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 2 (Digital → Traditional) Dietary intervention for healthy weight loss 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)
- Primary Outcome Measures
Name Time Method Concentration of interstitial glucose 15 days Only in the obese/overweight population.
Change in Interstitial Glucose (mgl/dl) measured continuously with the Freestyle glucometer (Abbott Laboratories)Blood lymphocytes 12 months 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.BMI 1 month Only in the obese/overweight population.
Change in body mass index (Kg/m2)Blood Glucose 1 month 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.
- Secondary Outcome Measures
Name Time Method Weight 1 month Weight change (Kg)
Heart Rate 1 month During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured in the study visits with an automatic Digital Blood Pressure Monitor Model M3 (OMRON HEALTHCARE UK, Kyoto, Japan).
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.Cognition 1 month Measured via the validated Mini-mental state examination (MMSE). In the Mini-mental state examination, the higher the score, the better the cognitive status.
Physical activity 1 month One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method:
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated International Physical Activity Questionnaire (USA Spanish version translated 3/2003 - Short last 7 DAYS self-administered version of the IPAQ - Revised August 2002).
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.Adinopectin 1 month 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.
WC 1 month Change in waist circumference (cm)
Body composition 1 month Change in % of fat mass
Dietary intake 1 month Traditional data-collection method: Two 3-day dietary records (for two working days and a holiday); Digital data-collection method: Pictures of food taken with a smartphone.
Mental health state 1 month One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method:
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated Depression Anxiety and Stress Scale - 21 (DASS-21). In the Depression Anxiety and Stress Scale, the higher the score, the greater the stress, anxiety and depression levels.
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.Percentage of glycated haemoglobin 1 month During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be only measured in the study visits with the blood tests.
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured continuously with the Freestyle glucometer (Abbott Laboratories), and in the study visits with the blood tests.Low density lipoprotein (LDL) 1 month 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.
Apo B 1 month 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.
Insulin 1 month 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.
Homeostatic model assessment (HOMA) 1 month 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.
Faecal microbiota 1 month Faecal microbiota taxonomic profiling through shotgun sequencing.
Sleep 1 month One same outcome measured during 2 weeks with one method and during the other 2 weeks with another method:
During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured via the validated Oviedo Sleep Questionnaire. In the Oviedo Sleep Questionnaire, the higher the score, the greater insomnia's severity.
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.Total cholesterol 1 month 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.
High density lipoprotein (HDL) 1 month 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.
Albumin 1 month 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.
Leptin 1 month 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.
Genotype 1 month Genotyping of single nucleotide genetic variants (SNPs) and specific mutations associated with metabolism, nutrition and immunodegenerative processes.
Blood pressure 1 month During the 2 weeks in which the participant gathers the information via Traditional data-collection method, it will be measured in the study visits with an automatic Digital Blood Pressure Monitor Model M3 (OMRON HEALTHCARE UK, Kyoto, Japan).
And during the 2 weeks in which the participant gathers the information via the Digital data-collection method, it will be measured with the Smartwatch Fitbit Sense.Health status and quality of life 1 month Measured via the validated Short Form-36 Health Survey (SF-36). In the Short Form-36 Health Survey, the higher the score, the better the quality of life and health status.
Triglycerides 1 month 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.
Glycated hemoglobin (HbA1c) 1 month 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.
C-reactive protein (CRP) 1 month 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.
Gut dysbiosis 1 month Lipopolysaccharide-binding protein (LBP) levels as an indirect measure of intestinal dysbiosis.
Apo A1 1 month 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.
Prealbumin 1 month 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.
Gene expression 1 month Expression panels in genes related to the regulation of metabolism, inflammation, immunity, oxidation, nutrition and immunodegenerative processes.
Trial Locations
- Locations (1)
IMDEA Food
🇪🇸Madrid, Spain