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

Chronic Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807243
• Other study ID #: IMD: PI-052
• Status: Completed
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: November 18, 2022

Study information

• Verified date: March 2023
• Source: IMDEA Food
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 18, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
Spain	IMDEA Food	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IMDEA Food

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. Erratum In: Lancet. 2021 Jun 26;397(10293):2466. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Only in the obese/overweight population.; Change in body mass index (Kg/m2)	1 month
Primary	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
Primary	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
Primary	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	Weight	Weight change (Kg)	1 month
Secondary	WC	Change in waist circumference (cm)	1 month
Secondary	Body composition	Change in % of fat mass	1 month
Secondary	Blood pressure	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.	1 month
Secondary	Heart Rate	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.	1 month
Secondary	Dietary intake	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.	1 month
Secondary	Physical activity	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.	1 month
Secondary	Sleep	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.	1 month
Secondary	Mental health state	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.	1 month
Secondary	Cognition	Measured via the validated Mini-mental state examination (MMSE). In the Mini-mental state examination, the higher the score, the better the cognitive status.	1 month
Secondary	Health status and quality of life	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.	1 month
Secondary	Percentage of glycated haemoglobin	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.	1 month
Secondary	Total cholesterol	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
Secondary	Low density lipoprotein (LDL)	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
Secondary	High density lipoprotein (HDL)	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
Secondary	Triglycerides	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
Secondary	Apo A1	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
Secondary	Apo B	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
Secondary	Insulin	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
Secondary	Glycated hemoglobin (HbA1c)	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
Secondary	Homeostatic model assessment (HOMA)	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
Secondary	Albumin	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
Secondary	Prealbumin	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
Secondary	C-reactive protein (CRP)	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
Secondary	Leptin	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
Secondary	Adinopectin	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
Secondary	Faecal microbiota	Faecal microbiota taxonomic profiling through shotgun sequencing.	1 month
Secondary	Gut dysbiosis	Lipopolysaccharide-binding protein (LBP) levels as an indirect measure of intestinal dysbiosis.	1 month
Secondary	Genotype	Genotyping of single nucleotide genetic variants (SNPs) and specific mutations associated with metabolism, nutrition and immunodegenerative processes.	1 month
Secondary	Gene expression	Expression panels in genes related to the regulation of metabolism, inflammation, immunity, oxidation, nutrition and immunodegenerative processes.	1 month

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