Non-communicable Diseases (NCD)CHANCENCT07558187
Systematic Examination of Health Inequalities: Documentation, Patterns, and Determinants
An observational study of Non-communicable Diseases (NCD) and Addiction to Opioids, run by University of Thessaly at 5 sites in Greece.
Trial summary
The existence of social inequalities is a major global issue and a salient challenge for the European Union. During COVID-19 pandemic, health disparities became more evident. Indeed, the low-income residents in several European countries, including Greece, had limited access to the healthcare system for several… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-communicable Diseases (NCD), Addiction to Opioids, Incarceration
- How many people
- 2,000 participants
- Where
- 5 sitesGreece
- Study dates
- 10 Mar 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sources of study populations: Hospitals; Other health centers and structures in cities, towns or villages; National Organization for the Prevention and Treatment of Addictions (EOPAE); Correctional facilities (prisons)
Who may be able to join
- Adults (>18 years of age)
- All healthy individuals who reside in rural and urban areas
- All patients with non-communicable diseases who reside in rural and urban areas
- Patients with opioid use disorders under medication for addiction treatment with methadone and buprenorphine
- Individuals incarcerated in correctional facilities
Who cannot join
- Minors (<18 years of age)
- Individuals with communicable diseases
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Greece5 sites, 5 recruiting
- Not yet recruiting
General Hospital of Larissa
Larissa
Grigoris Vlachakis, 2413504100 ext. 0030, gen.nosokomeio.laris@ghl.gr
- Recruiting
Health structures in the Region of Thessaly
Larissa
Maria Papagianni, 2431047115 ext. 0030, mpapag@uth.gr
- Not yet recruiting
National Organization for the Prevention and Treatment of Addictions (EOPAE)
Larissa
Vasilis Pinakas, 2410671842 ext. 0030, vpinakas@gmail.com
- Not yet recruiting
General Hospital of Trikala
Trikala
Lia Roganaki, Hospital Administrator, gnt.dioikitis@trikalahospital.gr
- Not yet recruiting
National Organization for the Prevention and Treatment of Addictions (EOPAE), Trikala
Trikala
Marina Papageorgiou, 2431026481 ext. 0030, papageorgiou.marina5@gmail.com
About this study
Official title: Assessment of Lifestyle Parameters and Biomarkers of Biochemistry and Physiology to Address Health Inequalities: An Exploratory Cohort Study
The existence of social inequalities is a major global issue and a salient challenge for the European Union. During COVID-19 pandemic, health disparities became more evident. Indeed, the low-income residents in several European countries, including Greece, had limited access to the healthcare system for several reasons. In addition, vulnerable populations, with patients suffering from opioid use disorders and incarcerated individuals being among them, do not have the same chances regarding health services, compared to the general population. According to the World Health Organization, physical activity is a key non-pharmaceutical intervention for both prevention of chronic non-communicable diseases and address of social health inequalities. Thus, this study will focus on specific population groups of the Region of Thessaly, Greece, who have limited access to healthcare services. It aims, primarily, to the assessment of demographic characteristics (i.e., body mass index, alcohol consumption, smoking, educational level etc), which are fundamental parameters for the assessment of health inequalities. Secondly, quality of life, physical activity levels and biomarkers in the level of Biochemistry (i.e., blood oxidative stress and inflammation) and Physiology (i.e., cardiorespiratory fitness, body composition) will be collected a well. All data will be integrated into an interactive digital platform that will be accessible by any putative stakeholder in the area of health system or administration. Based on scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders. To that end, the problem of limited access to health system that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local (i.e., in the province of Thessaly) and national (i.e., Greek) authorities. In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the issue of health inequalities.
Read the detailed description
Background: Health is defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The delectation of the highest attainable standard of health - and therefore quality of life - is a fundamental human right, regardless of race, religion, political opinion or socio-economic status. Thus, the key aspects of health definition according to WHO include multidimensionality (i.e., it covers the physical, mental, and social dimension), absence of illness (i.e., health is defined by positive well-being) and right to health (i.e., the attaining of the highest standard of health is a fundamental and universal right). Apart from the biological characteristics or individual choices, human health is also shaped to a significant extent by the social, economic and environmental conditions in which people are born, grow up, live, work and age. These conditions are referred to as social determinants of health and decisively influence morbidity, mortality and overall quality of life of populations. Health determinants can be distinguished into social and economic (i.e., income, educational level and occupational status), environmental (i.e., housing and working conditions, behavioral factors related to lifestyle) and biological factors (i.e., age, gender and heredity). The problem of health inequalities is a major issue worldwide and is inextricably linked to the aforementioned health determinants. Health inequalities have been extensively defined as health disparities, within and between countries, that are judged to be unfair, unjust, avoidable, and unnecessary (meaning: are neither inevitable nor unremediable) and that systematically burden populations rendered vulnerable by underlying social structures and political, economic, and legal institutions. Populations who suffer from health inequalities are, among others, the elderly and individuals with non-communicable diseases who reside in rural areas away from cities, as well as often socially marginalized populations, namely patients with opioid use disorders (OUDs) and incarcerated individuals. Indeed, the above-mentioned populations face limited access to health services due to poverty, low education, geographical isolation and lack of infrastructure, while factors such as social isolation, lack of insurance coverage and limited social structures enhance their vulnerability. In the biochemical level, patients with OUDs are characterized by impaired blood antioxidant mechanisms that highly influence their health. This is also the case for inmates in correctional facilities, since their nutrition is very poor in compounds like vitamins, which protect blood and tissues from elevated levels of oxidized substrates, hence they suffer from oxidative stress. As a result, they are vulnerable to diverse mental and other health issues. Among environmental factors, physical activity and dietary habits significantly affect the occurrence of chronic diseases and the overall health status of populations, therefore they could be considered as interventions towards tackling the vast public health problem of health inequalities. According to OECD, approximately 40% of adults do not perform sufficient physical activity, a fact that increases the risk of developing cardiovascular diseases and other chronic pathologies. The interaction of physical activity with the social determinants, characterized also as demographic data, highlights the multifactorial nature of health and the need for integrated public health interventions. According to the international guidelines, a crucial non-pharmaceutical intervention towards improvement of health and reduction of the frequency of non-communicable disease onset is exercise/physical activity. Aim: Based on the above, it appears that the problem of health inequalities is serious; however, the available data is limited, especially in Greece. To that end, this study aims to collect evidence from populations in the Region of Thessaly, Greece, who have limited access to health services and to both qualitatively and quantitatively document this problem. Methods: In particular, data from validated questionnaires, blood biomarkers and physiology measurements will be collected in three populations. These comprise members of the urban and rural population, who are both healthy or suffer from non-communicable disease, patients with OUDs who are under medication for addiction treatment with methadone or buprenorphine and incarcerated individuals. The data that will be collected from all volunteers are the following: Demographic data (e.g., body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status, financial status etc), physical activity level through the international physical activity questionnaire (IPAC), quality of life and mental health based on the internationally established questionnaire SF-36, and craving for heroin use (this applies only to the patients with OUDs). In sub-populations, biomarkers of blood oxidative stress and antioxidant potential (e.g., concentrations of glutathione and protein carbonyls, catalase activity and total antioxidant capacity), as well as cardiorespiratory fitness and body composition as indicators of physical activity and health status will also be obtained. All data will be integrated in an interactive digital platform and will be available to health stakeholders, the Greek authorities and everyone who needs to be informed about the problem of health inequalities. Based on these scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders. Anticipated outcomes: The problem of limited access to health services that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local and national authorities. In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the global issue of health inequalities.
- Conditions
- Non-communicable Diseases (NCD), Addiction to Opioids, Incarceration, Opioid-use Disorders
- Keywords
- Health inequalities, Physical activity/exercise, Demographics, Quality of life, Heroin craving, Oxidative stress, Antioxidants, Resting energy expenditure, Body composition, Alcohol, Body mass index, Smoking, Cardiorespiratory fitness, Opioid use disorders
- Medical subject headings
- Noncommunicable Diseases, Opioid-Related Disorders, Motor Activity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-communicable diseases - residents of rural areas | No intervention | |
| Patients with non-communicable diseases - residents of urban areas | No intervention | |
| Healthy volunteers - residents of rural areas | No intervention | |
| Healthy volunteers - residents of urban areas | No intervention | |
| Patients with opioid use disorders under medication for addiction treatment | No intervention | |
| Individuals incarcerated in correctional facilities (prisons) | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status and financial status will be collected among others through a questionnaire.
Measured: Data will be collected at Baseline
Secondary outcomes (11)
Physical activity
It will be measured through the international physical activity questionnaire (IPAC)
Measured: Data will be collected at Baseline
Quality of life
It will be measured through the SF-36 questionnaire. This instrument has a physical component and a mental component. Each domain is scored from 0 to 100. Higher score = better health or better quality of life.
Measured: Data will be collected at Baseline
Heroin craving
It will be measured using the heroin craving questionnaire (HCQ). The score is calculated with a 7-point Likert scale ranging from 1 (i.e., strongly disagree) to 7 (i.e., strongly agree). Higher values = higher craving for heroin use. It applies only to the patients with opioid use disorders.
Measured: Data will be collected at Baseline
Concentration of reduced glutathione (GSH)
The concentration of GSH, a crucial antioxidant metabolite, will be measured in the blood of sub-population of the volunteers
Measured: Data will be collected at Baseline
Concentration of protein carbonyls
Concentration of protein carbonyls, a biomarker of protein oxidation, will be measured in the blood of sub-population of the volunteers
Measured: Data will be collected at Baseline
Total antioxidant capacity (TAC)
TAC is crude biomarker of antioxidant status and will be measured in the blood of sub-population of the volunteers
Measured: Data will be collected at Baseline
Activity of catalase
Activity of catalase, a substantial antioxidant enzyme, will be measured in blood of sub-population of the volunteers
Measured: Data will be collected at Baseline
Cardiorespiratory fitness
A marker, which is associated to physical activity and health status, will be measured in sub-population of the volunteers. In particular, resting energy expenditure and resting heart rate will be assessed through metabolic gas analyzer.
Measured: Data will be collected at Baseline
Body fat percentage
It is associated to physical activity and health status and will be measured in sub-population of the volunteers through bioelectrical impedance analysis.
Measured: Data will be collected at Baseline
Lean body mass
It is associated to physical activity and health status and will be measured (in kg) in sub-population of the volunteers through bioelectrical impedance analysis.
Measured: Data will be collected at Baseline
Muscle mass
It is associated to physical activity and health status and will be measured (in kg) in sub-population of the volunteers through bioelectrical impedance analysis.
Measured: Data will be collected at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start10 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Non-communicable Diseases (NCD)Studies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Trikala, General Hospital of Larissa, National Organization for the Prevention and Treatment of Addictions (EOPAE), 5th Regional Health Authority of Thessaly & Sterea, Correctional Facility (Prison) of Trikala, Region of Thessaly, University of Thessaly, Department of Nutrition and Dietetics
- Responsible party
- Principal investigator, Aristidis Veskoukis, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558187
- Sponsor's protocol ID
- 98 / 25.07.2025
- Acronym
- CHANCE
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Veskoukis AS, Tsatsakis A, Kouretas D. Approaching reactive species in the frame of their clinical significance: A toxicological appraisal. Food Chem Toxicol. 2020 Apr;138:111206. doi: 10.1016/j.fct.2020.111206. Epub 2020 Feb 28.
PubMed 32113950Veskoukis AS, Kerasioti E, Priftis A, Kouka P, Spanidis Y, Makri S, Kouretas D. A battery of translational biomarkers for the assessment of the in vitro and in vivo antioxidant action of plant polyphenolic compounds: the biomarker issue. Current Opinion in Toxicology, 13:99-109, 2019.
Veskoukis AS, Margaritelis NV, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood and tissues: the NADPH network. Redox Rep. 2018 Dec;23(1):47-56. doi: 10.1080/13510002.2017.1392695. Epub 2017 Oct 31.
PubMed 29088980Veskoukis AS, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood. Biomarkers. 2016;21(3):208-17. doi: 10.3109/1354750X.2015.1126648. Epub 2016 Jan 26.
PubMed 26809994Dinas PC, On Behalf Of The Students Of Module Introduction To Systematic Reviews, Karaventza M, Liakou C, Georgakouli K, Bogdanos D, Metsios GS. Combined Effects of Physical Activity and Diet on Cancer Patients: A Systematic Review and Meta-Analysis. Nutrients. 2024 Jun 2;16(11):1749. doi: 10.3390/nu16111749.
PubMed 38892682Metsios GS, Moe RH, van der Esch M, van Zanten JJCSV, Fenton SAM, Koutedakis Y, Vitalis P, Kennedy N, Brodin N, Bostrom C, Swinnen TW, Tzika K, Niedermann K, Nikiphorou E, Fragoulis GE, Vlieland TPVM, Van den Ende CHM, Kitas GD; IMPACT-RMD Consortium. The effects of exercise on cardiovascular disease risk factors and cardiovascular physiology in rheumatoid arthritis. Rheumatol Int. 2020 Mar;40(3):347-357. doi: 10.1007/s00296-019-04483-6. Epub 2019 Dec 4.
PubMed 31802210Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504. Epub 2020 Apr 2.
PubMed 32249021Poulter M, Coe S, Graham CA, Leach B, Tammam J. A systematic review of the effect of dietary and nutritional interventions on the behaviours and mental health of prisoners. Br J Nutr. 2024 Jul 14;132(1):77-90. doi: 10.1017/S0007114524000849. Epub 2024 Apr 29.
PubMed 38682285Alves da Costa F, Verschuuren M, Andersen Y, Sturup-Toft S, Lopez-Acuna D, Ferreira-Borges C. The WHO Prison Health Framework: a framework for assessment of prison health system performance. Eur J Public Health. 2022 Aug 1;32(4):565-570. doi: 10.1093/eurpub/ckac020.
PubMed 35373832Schoenthaler, S., Gast, D., Giltay, E. J., & Amos, S. (2023). The Effects of Vitamin-Mineral Supplements on Serious Rule Violations in Correctional Facilities for Young Adult Male Inmates: A Randomized Controlled Trial. Crime & Delinquency, 69(4), 822-840.
Leventelis C, Barmpas PT, Nellas I, Tasoulis S, Veskoukis AS, Tsironi M. COVID-19 Pandemic Detrimentally Affects Craving and Quality of Life in Patients Under Medication-Assisted Treatment with Buprenorphine and Methadone: The Issue of Medication Dose. Psychiatry International, 5, 867-882, 2024.
Leventelis C, Makri S, Ververi A, Papageorgiou K, Tentolouri A, Mountzouridi E, Tekos F, Barmpas PT, Tasoulis S, Metsios GS, Kouretas D, Veskoukis AS. Pomegranate juice ameliorates craving and oxidative stress on patients under medication for opioid addiction treatment with methadone and buprenorphine: A ranzomised controlled trial. Clin Nutr ESPEN. 2025 Apr;66:34-45. doi: 10.1016/j.clnesp.2025.01.025. Epub 2025 Jan 10.
PubMed 39798867Leventelis C, Veskoukis AS, Rojas Gil AP, Papadopoulos P, Garderi M, Angeli A, Kampitsi A, Tsironi M. Methadone and Buprenorphine as Medication for Addiction Treatment Diversely Affect Inflammation and Craving Depending on Their Doses. Pharmacy (Basel). 2025 Mar 6;13(2):40. doi: 10.3390/pharmacy13020040.
PubMed 40126313Leventelis C, Barmpas PT, Kampitsi A, Iliopoulou K, Toutouktsi N, Malakopoulos P, Tasoulis S, Veskoukis AS. Pomegranate Juice Consumption Improves Sleep Quality and Melatonin Concentration of Patients With Opioid Use Disorders Under Medication-Assisted Treatment With Methadone and Buprenorphine: A Randomized Controlled Trial. Subst Use Addctn J. 2025 Oct;46(4):981-993. doi: 10.1177/29767342251342666. Epub 2025 Jul 25.
PubMed 40709794Edwards A, Hung R, Levin JB, Forthun L, Sajatovic M, McVoy M. Health Disparities among Rural Individuals with Mental Health Conditions: A Systematic Literature Review. Rural Ment Health. 2023 Jul;47(3):163-178. doi: 10.1037/rmh0000228. Epub 2023 May 11.
PubMed 37638091
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lifestyle Parameters and Biomarkers of Biochemistry and Physiology to Address Health Inequalities: An Exploratory Cohort Study
- ClinicalTrials.gov ID
- NCT07558187
- Acronym / sponsor ID
- CHANCE / 98 / 25.07.2025
- Conditions
- Non-communicable Diseases (NCD), Addiction to Opioids, Incarceration, Opioid-use Disorders
- Keywords
- Health inequalities, Physical activity/exercise, Demographics, Quality of life, Heroin craving, Oxidative stress, Antioxidants, Resting energy expenditure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- General Hospital of Trikala, General Hospital of Larissa, National Organization for the Prevention and Treatment of Addictions (EOPAE), 5th Regional Health Authority of Thessaly & Sterea, Correctional Facility (Prison) of Trikala, Region of Thessaly, University of Thessaly, Department of Nutrition and Dietetics
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The existence of social inequalities is a major global issue and a salient challenge for the European Union. During COVID-19 pandemic, health disparities became more evident. Indeed, the low-income residents in several European countries, including Greece, had limited access to the healthcare system for several reasons. In addition, vulnerable populations, with patients suffering from opioid use disorders and incarcerated individuals being among them, do not have the same chances regarding health services, compared to the general population. According to the World Health Organization, physical activity is a key non-pharmaceutical intervention for both prevention of chronic non-communicable diseases and address of social health inequalities. Thus, this study will focus on specific population groups of the Region of Thessaly, Greece, who have limited access to healthcare services. It aims, primarily, to the assessment of demographic characteristics (i.e., body mass index, alcohol consumption, smoking, educational level etc), which are fundamental parameters for the assessment of health inequalities. Secondly, quality of life, physical activity levels and biomarkers in the level of Biochemistry (i.e., blood oxidative stress and inflammation) and Physiology (i.e., cardiorespiratory fitness, body composition) will be collected a well. All data will be integrated into an interactive digital platform that will be accessible by any putative stakeholder in the area of health system or administration. Based on scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders. To that end, the problem of limited access to health system that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local (i.e., in the province of Thessaly) and national (i.e., Greek) authorities. In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the issue of health inequalities.
Detailed description
Background: Health is defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The delectation of the highest attainable standard of health - and therefore quality of life - is a fundamental human right, regardless of race, religion, political opinion or socio-economic status. Thus, the key aspects of health definition according to WHO include multidimensionality (i.e., it covers the physical, mental, and social dimension), absence of illness (i.e., health is defined by positive well-being) and right to health (i.e., the attaining of the highest standard of health is a fundamental and universal right). Apart from the biological characteristics or individual choices, human health is also shaped to a significant extent by the social, economic and environmental conditions in which people are born, grow up, live, work and age. These conditions are referred to as social determinants of health and decisively influence morbidity, mortality and overall quality of life of populations. Health determinants can be distinguished into social and economic (i.e., income, educational level and occupational status), environmental (i.e., housing and working conditions, behavioral factors related to lifestyle) and biological factors (i.e., age, gender and heredity). The problem of health inequalities is a major issue worldwide and is inextricably linked to the aforementioned health determinants. Health inequalities have been extensively defined as health disparities, within and between countries, that are judged to be unfair, unjust, avoidable, and unnecessary (meaning: are neither inevitable nor unremediable) and that systematically burden populations rendered vulnerable by underlying social structures and political, economic, and legal institutions. Populations who suffer from health inequalities are, among others, the elderly and individuals with non-communicable diseases who reside in rural areas away from cities, as well as often socially marginalized populations, namely patients with opioid use disorders (OUDs) and incarcerated individuals. Indeed, the above-mentioned populations face limited access to health services due to poverty, low education, geographical isolation and lack of infrastructure, while factors such as social isolation, lack of insurance coverage and limited social structures enhance their vulnerability. In the biochemical level, patients with OUDs are characterized by impaired blood antioxidant mechanisms that highly influence their health. This is also the case for inmates in correctional facilities, since their nutrition is very poor in compounds like vitamins, which protect blood and tissues from elevated levels of oxidized substrates, hence they suffer from oxidative stress. As a result, they are vulnerable to diverse mental and other health issues. Among environmental factors, physical activity and dietary habits significantly affect the occurrence of chronic diseases and the overall health status of populations, therefore they could be considered as interventions towards tackling the vast public health problem of health inequalities. According to OECD, approximately 40% of adults do not perform sufficient physical activity, a fact that increases the risk of developing cardiovascular diseases and other chronic pathologies. The interaction of physical activity with the social determinants, characterized also as demographic data, highlights the multifactorial nature of health and the need for integrated public health interventions. According to the international guidelines, a crucial non-pharmaceutical intervention towards improvement of health and reduction of the frequency of non-communicable disease onset is exercise/physical activity. Aim: Based on the above, it appears that the problem of health inequalities is serious; however, the available data is limited, especially in Greece. To that end, this study aims to collect evidence from populations in the Region of Thessaly, Greece, who have limited access to health services and to both qualitatively and quantitatively document this problem. Methods: In particular, data from validated questionnaires, blood biomarkers and physiology measurements will be collected in three populations. These comprise members of the urban and rural population, who are both healthy or suffer from non-communicable disease, patients with OUDs who are under medication for addiction treatment with methadone or buprenorphine and incarcerated individuals. The data that will be collected from all volunteers are the following: Demographic data (e.g., body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status, financial status etc), physical activity level through the international physical activity questionnaire (IPAC), quality of life and mental health based on the internationally established questionnaire SF-36, and craving for heroin use (this applies only to the patients with OUDs). In sub-populations, biomarkers of blood oxidative stress and antioxidant potential (e.g., concentrations of glutathione and protein carbonyls, catalase activity and total antioxidant capacity), as well as cardiorespiratory fitness and body composition as indicators of physical activity and health status will also be obtained. All data will be integrated in an interactive digital platform and will be available to health stakeholders, the Greek authorities and everyone who needs to be informed about the problem of health inequalities. Based on these scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders. Anticipated outcomes: The problem of limited access to health services that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local and national authorities. In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the global issue of health inequalities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with non-communicable diseases - residents of rural areas | – | –No intervention |
| Patients with non-communicable diseases - residents of urban areas | – | –No intervention |
| Healthy volunteers - residents of rural areas | – | –No intervention |
| Healthy volunteers - residents of urban areas | – | –No intervention |
| Patients with opioid use disorders under medication for addiction treatment | – | –No intervention |
| Individuals incarcerated in correctional facilities (prisons) | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sources of study populations: Hospitals; Other health centers and structures in cities, towns or villages; National Organization for the Prevention and Treatment of Addictions (EOPAE); Correctional facilities (prisons)
Key inclusion criteria (5 listed)
- Adults (>18 years of age)
- All healthy individuals who reside in rural and urban areas
- All patients with non-communicable diseases who reside in rural and urban areas
- Patients with opioid use disorders under medication for addiction treatment with methadone and buprenorphine
- Individuals incarcerated in correctional facilities
Key exclusion criteria (2 listed)
- Minors (<18 years of age)
- Individuals with communicable diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic data
Time frame: Data will be collected at Baseline
Body mass index, smoking, alcohol consumption, place of residence, health insurance, educational status, family status and financial status will be collected among others through a questionnaire.
11 secondary outcomes
Physical activity
Time frame: Data will be collected at Baseline
Quality of life
Time frame: Data will be collected at Baseline
Heroin craving
Time frame: Data will be collected at Baseline
Concentration of reduced glutathione (GSH)
Time frame: Data will be collected at Baseline
Concentration of protein carbonyls
Time frame: Data will be collected at Baseline
Total antioxidant capacity (TAC)
Time frame: Data will be collected at Baseline
Activity of catalase
Time frame: Data will be collected at Baseline
Cardiorespiratory fitness
Time frame: Data will be collected at Baseline
Body fat percentage
Time frame: Data will be collected at Baseline
Lean body mass
Time frame: Data will be collected at Baseline
Muscle mass
Time frame: Data will be collected at Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 32113950Veskoukis AS, Tsatsakis A, Kouretas D. Approaching reactive species in the frame of their clinical significance: A toxicological appraisal. Food Chem Toxicol. 2020 Apr;138:111206. doi: 10.1016/j.fct.2020.111206. Epub 2020 Feb 28.
- BackgroundVeskoukis AS, Kerasioti E, Priftis A, Kouka P, Spanidis Y, Makri S, Kouretas D. A battery of translational biomarkers for the assessment of the in vitro and in vivo antioxidant action of plant polyphenolic compounds: the biomarker issue. Current Opinion in Toxicology, 13:99-109, 2019.
- Background: PubMed 29088980Veskoukis AS, Margaritelis NV, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood and tissues: the NADPH network. Redox Rep. 2018 Dec;23(1):47-56. doi: 10.1080/13510002.2017.1392695. Epub 2017 Oct 31.
- Background: PubMed 26809994Veskoukis AS, Kyparos A, Paschalis V, Nikolaidis MG. Spectrophotometric assays for measuring redox biomarkers in blood. Biomarkers. 2016;21(3):208-17. doi: 10.3109/1354750X.2015.1126648. Epub 2016 Jan 26.
- Background: PubMed 38892682Dinas PC, On Behalf Of The Students Of Module Introduction To Systematic Reviews, Karaventza M, Liakou C, Georgakouli K, Bogdanos D, Metsios GS. Combined Effects of Physical Activity and Diet on Cancer Patients: A Systematic Review and Meta-Analysis. Nutrients. 2024 Jun 2;16(11):1749. doi: 10.3390/nu16111749.
- Background: PubMed 31802210Metsios GS, Moe RH, van der Esch M, van Zanten JJCSV, Fenton SAM, Koutedakis Y, Vitalis P, Kennedy N, Brodin N, Bostrom C, Swinnen TW, Tzika K, Niedermann K, Nikiphorou E, Fragoulis GE, Vlieland TPVM, Van den Ende CHM, Kitas GD; IMPACT-RMD Consortium. The effects of exercise on cardiovascular disease risk factors and cardiovascular physiology in rheumatoid arthritis. Rheumatol Int. 2020 Mar;40(3):347-357. doi: 10.1007/s00296-019-04483-6. Epub 2019 Dec 4.
- Background: PubMed 32249021Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504. Epub 2020 Apr 2.
- Background: PubMed 38682285Poulter M, Coe S, Graham CA, Leach B, Tammam J. A systematic review of the effect of dietary and nutritional interventions on the behaviours and mental health of prisoners. Br J Nutr. 2024 Jul 14;132(1):77-90. doi: 10.1017/S0007114524000849. Epub 2024 Apr 29.
- Background: PubMed 35373832Alves da Costa F, Verschuuren M, Andersen Y, Sturup-Toft S, Lopez-Acuna D, Ferreira-Borges C. The WHO Prison Health Framework: a framework for assessment of prison health system performance. Eur J Public Health. 2022 Aug 1;32(4):565-570. doi: 10.1093/eurpub/ckac020.
- BackgroundSchoenthaler, S., Gast, D., Giltay, E. J., & Amos, S. (2023). The Effects of Vitamin-Mineral Supplements on Serious Rule Violations in Correctional Facilities for Young Adult Male Inmates: A Randomized Controlled Trial. Crime & Delinquency, 69(4), 822-840.
- BackgroundLeventelis C, Barmpas PT, Nellas I, Tasoulis S, Veskoukis AS, Tsironi M. COVID-19 Pandemic Detrimentally Affects Craving and Quality of Life in Patients Under Medication-Assisted Treatment with Buprenorphine and Methadone: The Issue of Medication Dose. Psychiatry International, 5, 867-882, 2024.
- Background: PubMed 39798867Leventelis C, Makri S, Ververi A, Papageorgiou K, Tentolouri A, Mountzouridi E, Tekos F, Barmpas PT, Tasoulis S, Metsios GS, Kouretas D, Veskoukis AS. Pomegranate juice ameliorates craving and oxidative stress on patients under medication for opioid addiction treatment with methadone and buprenorphine: A ranzomised controlled trial. Clin Nutr ESPEN. 2025 Apr;66:34-45. doi: 10.1016/j.clnesp.2025.01.025. Epub 2025 Jan 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-communicable Diseases (NCD) and Addiction to Opioids, run by University of Thessaly at 5 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aristidis S Veskoukis, Associate Professor (2431047114 ext. 0030, veskoukis@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: Data will be collected at Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07558187, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.