Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05815732 |
| Other study ID # |
HEBE |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 8, 2022 |
| Est. completion date |
July 20, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University of Milan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main objective of this clinical trial is to test the effects of the personalized
intervention based on physical exercise, on clinical variables and circulating markers, in a
population of employees of the University of Milan (UMilan).
The HEBE study will include two phases:
PHASE 1:
All UMilan employees will be asked to voluntarily complete an anonymous online questionnaire,
in order to gather information about their lifestyle (physical activity, diet, cigarette
smoking, etc) (zero time: T0); at the end of the compilation, indications on how to improve
the lifestyle will be provided. These indications will also be present and available for
consultation in a special section of the site on the "HEBE" site, with UMilan domain
(www.hebe.unimi.it).
After 6 months, all UMilan employees will receive a second invitation to voluntarily complete
the same questionnaire, in order to evaluate any changes, in terms of lifestyle improvement
(time one: T1).
PHASE 2:
100 eligible subjects who have expressed their availability in the initial questionnaire,
will be identified to undergo a lifestyle improvement protocol based mainly on the
prescription of a personalized exercise program, which will define modalities, intensity,
duration, frequency and progression of the exercise. For each subject, at T0 and T1 (after 6
months), biological samples will be collected (blood, urine, saliva and nasal swab), which
will be used to: i) set up a biobank shared by the members of the HEBE consortium; ii)
identify biomarkers able to monitor the effect of physical exercise on the characteristics of
the frailty under examination. Furthermore, both at T0 and T1 questionnaires will be
completed and carried out clinical evaluations (anamnesis, physical examination, tests for
the study of the autonomic nervous system, bio-impedance test, evaluation/estimate of maximal
oxygen consumption, ECG).
Description:
Non-communicable diseases (NCDs) are the cause of premature aging and death of 41 million
people each year, accounting for 71% of all deaths globally. NCDs are closely linked to rapid
urbanization and globalization. In this context, unsustainable lifestyles, characterized by a
lack of physical activity, trigger the progression of NCDs. To date, it is estimated that
around 41% of Europeans (and as many as 60% of Italians) do not engage in any type of
physical activity (even light) during the week and this increases the risk of chronic
diseases: 86% of deaths are attributable to cardiovascular disease, cancer, chronic
respiratory disease and type 2 diabetes, a disease from which approximately 52 million people
suffer in Europe (8.4% of men and 7.8% of women among 20 and 79 years of age).
Over the years, the progressive increase in the number of senescent cells can lead to
tissue/organ dysfunction. In an attempt to respond to this process, senescent cells undergo
metabolic modifications leading to increased secretion of soluble factors (e.g. cytokines,
chemokines, growth factors, metalloproteases), which thus modulate their microenvironment
through the removal of damaged cells by the recruitment of phagocytes and stimulating cell
differentiation and proliferation for tissue renewal. The secretion of pro-inflammatory
molecules and the activation of immune cells contributes to the generation of a low-grade
chronic pro-inflammatory state known as "inflammaging", which is at the root of most
age-related diseases. Furthermore, upregulation of mitogenic and pro-angiogenic pathways
dangerously increases the risk of oncogenic transformation. The modulation of the complex of
alterations that make up inflammaging could therefore be the key to guaranteeing healthy
aging and reducing the risk of developing early NCD. A very promising approach to controlling
inflammaging involves focusing on reducing the risk factors associated with these diseases by
proposing alternative development models.
The main challenge of the HEBE project as a whole therefore consists in addressing three
fundamental questions:
1. What primary prevention approaches can we develop, considering all phases of the
individual's life, to ensure an improvement in the quality of life and health status of
the population, with a positive impact on the socio-economic system of the area?
2. What intervention protocols based on physical exercise, combined with diet and any
pharmacological/pharmaceutical approach, can we propose to frail subjects, in order to
intervene on "inflammaging", to increase life expectancy and healthy ageing?
3. Which inflammaging markers (biomarkers and other clinical indicators) can we measure and
integrate to define the risk of developing NCD, especially in frail subjects, to guide
integrated personalized preventive interventions (precision/personalized healthcare)?
General objectives of the trial
The main objective of this study is the evaluation of the effects of the personalized
intervention based on physical exercise, on clinical parameters and circulating markers, in a
population of employees of the University of Milan (UMilan).
In Research Line 1- a pilot study will be conducted involving UMilan employees which will
include two phases:
PHASE 1:
All UMilan employees will be asked to voluntarily complete an anonymous online questionnaire,
in order to gather information about their lifestyle (physical activity, diet, cigarette
smoking, etc.) (zero time: T0); at the end of the compilation, indications on how to improve
the lifestyle will be provided. These indications will also be present and available for
consultation in a special section of the site on the "HEBE" site, with UMilan domain
(www.hebe.unimi.it), in a special section.
After 6 months, all UMilan employees will receive a second invitation to voluntarily complete
the same questionnaire, in order to evaluate any changes, in terms of lifestyle improvement
(time one: T1).
PHASE 2:
100 eligible subjects who have expressed their availability in the initial questionnaire,
will be identified to undergo a lifestyle improvement protocol based mainly on the
prescription of a personalized exercise program, which will define modalities, intensity,
duration, frequency, and progression of the exercise. For each subject, at T0 and T1 (after 6
months), biological samples will be collected (blood, urine, saliva and nasal swab), which
will be used to: i) set up a biobank shared by the members of the HEBE consortium; ii)
identify biomarkers able to monitor the effect of physical exercise on the characteristics of
the frailty under examination. Furthermore, both at T0 and T1 questionnaires will be
completed and carried out clinical evaluations (anamnesis, physical examination, tests for
the study of the autonomic nervous system, bio-impedance test, evaluation/estimate of maximal
oxygen consumption, ECG) useful for: i) verifying the clinical conditions of the subject; ii)
obtain useful parameters for the customized definition of the intervention program; iii)
verify the effectiveness of the intervention at T1; iv) assess the association between
clinical indicators and biomarkers.
