LONGEVITY 1NCT04840381
Dietary Habits and Lifestyle of Nonagenarians and Centenarians in the Italian Abruzzo Region
An observational study of LONGEVITY 1 and Diet Habit, run by University of Teramo at 1 site in Italy.
Trial summary
The "CenTEnari" study is a cross-sectional study aiming at suveying the dietary and lifestyle habits of nonagenarians and centenarianss of citizens of the Abruzzo region, Italy. Read more about this study
- Who is it for?
- Ages 90 years and olderHealthy volunteers can take part
- Conditions the study is for
- LONGEVITY 1, Diet Habit, Fasting
- What is being tested?
- Questionnaire administrations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Volunteers borned in the Abruzzo region and living in the Abruzzo region, or spent most of their life in the Abruzzo region.
Who may be able to join
- Age ≥ 90 years old
- Borned and living for most of their life in the Abruzzo region.
Who cannot join
- Age lower 80 years old.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Teramo - Faculty of Bioscience and Agro-Food and Environmental Technology
Teramo, 64100
About this study
The "CenTEnari" study is a cross-sectional study aiming at suveying the dietary and lifestyle habits of nonagenarians and centenarianss of citizens of the Abruzzo region, Italy.
Read the detailed description
Several epidemiological studies indicates that diet and physical activity are two pivotal pillars for the maintenance the of the health status and for longevity. These two last factors seem to be strictly linked between them, as demonstrated by some studies on the so called "Blue zones", particular lands in the planet where longevity rate - in terms of nonagenarians and centenarians - is particularly high. In these studies, it has been pointed out that, other than genetics, individuals following dietary regimens with lower consumption of available carbohydrates and processed foods, higher consumption of fruit, vegetables, cereals and pulses and moderate intake of meat, fish and dairy foods live longer and in a healthier status.
The Abruzzo region is characterized by a great gastronomical variability, due also to the particular geographical characterization, with a few kilometer distance between sea and mountains. However, most of these dietary habits tend to stick in a valuable way to Mediterranean Diet, a dietary regimen listed in 2010 in the Representative List of the Intangible Cultural Heritage of Humanity by UNESCO. Intriguingly, the Mediterranean Diet is based on the intake of the above mentioned food groups, plus a recognized key role of the physical activity and conviviality in the meal consumption.
Particularly, in the internal and mountainous part of the Abruzzo region, it has been found that the local citizens followed/follows a typical "dietary practice" called "sdijuno", which in local dialect means "to break the fasting of the night". In fact, "sdijuno" was the first abundant meal of the day - usually at mid-morning, based on the local vegetable-based foods - following the previous frugal dinner and breakfast meals. Thus, it can be hypothesized of 14-16 hours of almost fasting period. This evidence falls into the most recent findings showing the importance to consume meals in the middle part of the day and limiting the caloric intake during evening time, when metabolism tends to decrease according to body circadian rhythm.
Based on these premises, the aim of the present study is to survey the dietary habits of nonagenarians and centenarians of the Abruzzo region - particularly focusing on their adherence to "sdijuno" practice - as well as physical activity and to collect personal data and health status information. Then, it will be investigated whether the adherence to the "sdijuno" dietary practice is relevant among the nonagenarians and centenarians and there is a link between this practice and the longevity of the volunteers. To do this, an ad hoc questionnaire has been set-up and will be administered to register food frequency and meal time, main recipes, physical activity habits, health status.
- Conditions
- LONGEVITY 1, Diet Habit, Fasting, Activity, Motor
- Being tested
- Questionnaire administrations
- Keywords
- Sdijuno, Centenarians, Dietary habits, Longevity, Fasting
- Medical subject headings
- Feeding Behavior, Fasting, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationsBehavioural
Administration of an ad hoc questionnaire to register food frequency consumption and meal time, main recipes; phisical activity questionnaire and list of questions concerning the previous and actual health status of participants
| Study group | Role | What they receive |
|---|---|---|
| Nonagenarians and Centenarians | Nonagenarians and Centenarians borned and living for most of their life in the Abruzzo region. Receives: Behavioral: Questionnaire administrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of intake of food groups
Observed information regarding the frequency of the consumption different food groups during subejects' period of youth
Measured: 1 year
Secondary outcomes (5)
Moderate or Vigorous Physical Activity Per Week
Self reported practice of moderate or vigorous physical activity per week during subejects' period of youth and old age (minutes-per-week)
Measured: 1 Week
Mealtime
Self reported information regarding the daily mealtime during subejects' period of youth and old age (hour and minutes of meal eating)
Measured: 1 Day
Body weight
Self reported body weight (kg)
Measured: 1 Day
Body height
Self reported body height (m)
Measured: 1 Day
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jan 2019
- Primary completion1 Mar 2021
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LONGEVITY 1Studies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Teramo
- Sponsor type
- University, hospital or other
- Collaborators
- DAngelino
- Responsible party
- Principal investigator, Mauro Serafini, University of Teramo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840381
- Sponsor's protocol ID
- CenTEnari
- Status last verified
- Nov 2023
- First submitted
- 10 Mar 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Angelino D, Godos J, Ghelfi F, Tieri M, Titta L, Lafranconi A, Marventano S, Alonzo E, Gambera A, Sciacca S, Buscemi S, Ray S, Galvano F, Del Rio D, Grosso G. Fruit and vegetable consumption and health outcomes: an umbrella review of observational studies. Int J Food Sci Nutr. 2019 Sep;70(6):652-667. doi: 10.1080/09637486.2019.1571021. Epub 2019 Feb 15.
PubMed 30764679Gensous N, Franceschi C, Santoro A, Milazzo M, Garagnani P, Bacalini MG. The Impact of Caloric Restriction on the Epigenetic Signatures of Aging. Int J Mol Sci. 2019 Apr 24;20(8):2022. doi: 10.3390/ijms20082022.
PubMed 31022953Magrone T, Perez de Heredia F, Jirillo E, Morabito G, Marcos A, Serafini M. Functional foods and nutraceuticals as therapeutic tools for the treatment of diet-related diseases. Can J Physiol Pharmacol. 2013 Jun;91(6):387-96. doi: 10.1139/cjpp-2012-0307. Epub 2013 Apr 12.
PubMed 23745830Poulain M, Pes GM, Grasland C, Carru C, Ferrucci L, Baggio G, Franceschi C, Deiana L. Identification of a geographic area characterized by extreme longevity in the Sardinia island: the AKEA study. Exp Gerontol. 2004 Sep;39(9):1423-9. doi: 10.1016/j.exger.2004.06.016.
PubMed 15489066
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Habits and Lifestyle of Nonagenarians and Centenarians in the Italian Abruzzo Region
- ClinicalTrials.gov ID
- NCT04840381
- Acronym / sponsor ID
- CenTEnari
- Conditions
- LONGEVITY 1, Diet Habit, Fasting, Activity, Motor
- Keywords
- Sdijuno, Centenarians, Dietary habits, Longevity, Fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of TeramoUniversity, hospital or other
- Collaborators
- DAngelino
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Apr 2021 (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 "CenTEnari" study is a cross-sectional study aiming at suveying the dietary and lifestyle habits of nonagenarians and centenarianss of citizens of the Abruzzo region, Italy.
Detailed description
Several epidemiological studies indicates that diet and physical activity are two pivotal pillars for the maintenance the of the health status and for longevity. These two last factors seem to be strictly linked between them, as demonstrated by some studies on the so called "Blue zones", particular lands in the planet where longevity rate - in terms of nonagenarians and centenarians - is particularly high. In these studies, it has been pointed out that, other than genetics, individuals following dietary regimens with lower consumption of available carbohydrates and processed foods, higher consumption of fruit, vegetables, cereals and pulses and moderate intake of meat, fish and dairy foods live longer and in a healthier status.
The Abruzzo region is characterized by a great gastronomical variability, due also to the particular geographical characterization, with a few kilometer distance between sea and mountains. However, most of these dietary habits tend to stick in a valuable way to Mediterranean Diet, a dietary regimen listed in 2010 in the Representative List of the Intangible Cultural Heritage of Humanity by UNESCO. Intriguingly, the Mediterranean Diet is based on the intake of the above mentioned food groups, plus a recognized key role of the physical activity and conviviality in the meal consumption.
Particularly, in the internal and mountainous part of the Abruzzo region, it has been found that the local citizens followed/follows a typical "dietary practice" called "sdijuno", which in local dialect means "to break the fasting of the night". In fact, "sdijuno" was the first abundant meal of the day - usually at mid-morning, based on the local vegetable-based foods - following the previous frugal dinner and breakfast meals. Thus, it can be hypothesized of 14-16 hours of almost fasting period. This evidence falls into the most recent findings showing the importance to consume meals in the middle part of the day and limiting the caloric intake during evening time, when metabolism tends to decrease according to body circadian rhythm.
Based on these premises, the aim of the present study is to survey the dietary habits of nonagenarians and centenarians of the Abruzzo region - particularly focusing on their adherence to "sdijuno" practice - as well as physical activity and to collect personal data and health status information. Then, it will be investigated whether the adherence to the "sdijuno" dietary practice is relevant among the nonagenarians and centenarians and there is a link between this practice and the longevity of the volunteers. To do this, an ad hoc questionnaire has been set-up and will be administered to register food frequency and meal time, main recipes, physical activity habits, health status.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonagenarians and Centenarians | – | Behavioral: Questionnaire administrationsNonagenarians and Centenarians borned and living for most of their life in the Abruzzo region. |
Who may qualify
- Ages
- 90 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Volunteers borned in the Abruzzo region and living in the Abruzzo region, or spent most of their life in the Abruzzo region.
Key inclusion criteria (2 listed)
- Age ≥ 90 years old
- Borned and living for most of their life in the Abruzzo region.
Key exclusion criteria (1 listed)
- Age lower 80 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administrationsAdministration of an ad hoc questionnaire to register food frequency consumption and meal time, main recipes; phisical activity questionnaire and list of questions concerning the previous and actual health status of participants | Behavioural | Nonagenarians and Centenarians |
Primary outcome
Frequency of intake of food groups
Time frame: 1 year
Observed information regarding the frequency of the consumption different food groups during subejects' period of youth
5 secondary outcomes
Moderate or Vigorous Physical Activity Per Week
Time frame: 1 Week
Mealtime
Time frame: 1 Day
Body weight
Time frame: 1 Day
Body height
Time frame: 1 Day
Body Mass Index (BMI)
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 30764679Angelino D, Godos J, Ghelfi F, Tieri M, Titta L, Lafranconi A, Marventano S, Alonzo E, Gambera A, Sciacca S, Buscemi S, Ray S, Galvano F, Del Rio D, Grosso G. Fruit and vegetable consumption and health outcomes: an umbrella review of observational studies. Int J Food Sci Nutr. 2019 Sep;70(6):652-667. doi: 10.1080/09637486.2019.1571021. Epub 2019 Feb 15.
- Background: PubMed 31022953Gensous N, Franceschi C, Santoro A, Milazzo M, Garagnani P, Bacalini MG. The Impact of Caloric Restriction on the Epigenetic Signatures of Aging. Int J Mol Sci. 2019 Apr 24;20(8):2022. doi: 10.3390/ijms20082022.
- Background: PubMed 23745830Magrone T, Perez de Heredia F, Jirillo E, Morabito G, Marcos A, Serafini M. Functional foods and nutraceuticals as therapeutic tools for the treatment of diet-related diseases. Can J Physiol Pharmacol. 2013 Jun;91(6):387-96. doi: 10.1139/cjpp-2012-0307. Epub 2013 Apr 12.
- Background: PubMed 15489066Poulain M, Pes GM, Grasland C, Carru C, Ferrucci L, Baggio G, Franceschi C, Deiana L. Identification of a geographic area characterized by extreme longevity in the Sardinia island: the AKEA study. Exp Gerontol. 2004 Sep;39(9):1423-9. doi: 10.1016/j.exger.2004.06.016.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LONGEVITY 1 and Diet Habit, run by University of Teramo at 1 site in Italy.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of intake of food groups (time frame: 1 year). 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 NCT04840381, which also lists 4 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 29 Nov 2023.