Systemic DiseaseNCT05509075
Nutraceuticals and Functional Foods
An observational study of Systemic Disease and Skin Diseases, run by University of Catanzaro at 1 site in Italy.
Trial summary
Supplements and functional foods are now readily available and usable by the general population. Many supplemnets are commonly used in poly-treated patients where interactions or adverse events may develop, therefore we evaluate in the rela life the use of nutraceuticals, their clinical effects and the development of… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Systemic Disease, Skin Diseases, Memory Disorders
- What is being tested?
- nutraceuticals
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2019to 29 Nov 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 18 to 95 years
- All sexes
- Adult, Older adult
Study population: At admission (T0), the anthropometric data and the functional clinical data of each patient (or healthy subject) will be collected. An aliquot of the blood sample will be used for transcriptomic evaluation. Immediately after the clinical and laboratory evaluation, each GP or each specialist will decide the type of nutraceutical or functional food to be used. For example, in elderly patient with osteoarthritis disorders can use a supplement based on chondroitin or glucosamine or other substances (or functional foods) with specific claims, as well as a patient with hypercholesterolemia without other risk factors can use a supplement containing monacolin K or flavonoids or other functional foods with claims specific. Similarly, patients with gastrointestinal or genitourinary disorders can use functional food based on probiotics or substances with a particular activity and comply with international claims.
Who may be able to join
- Patients or healthy subjects of both sexes and aged> 18 years Patients are not on supplement therapy or functional foods for any purpose.
- Patients who have given their consent to participate in the study
Who cannot join
- Patients with severe renal or liver failure, neoplastic diseases or those with allergy to supplement or functional food , and those who do not sign the consent will be excluded from the study. Informed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Luca Gallelli
Catanzaro, 88100
Luca Gallelli, MD, gallelli@unicz.it
About this study
Official title: Valutazione Dell'Efficacia e Della Sicurezza Dei Nutraceutici Utilizzati Nella Popolazione Generale Per il Trattamento di Patologie Sistemiche o Locali
Supplements and functional foods are now readily available and usable by the general population. Many supplemnets are commonly used in poly-treated patients where interactions or adverse events may develop, therefore we evaluate in the rela life the use of nutraceuticals, their clinical effects and the development of adverse drug reactions
Read the detailed description
Supplements (also called nutraceuticals because they derive from natural substances) and functional foods are now readily available and usable by the general population. The term "nutraceutical" derives from a fusion of the terms "nutritional" and "pharmaceutical" y was used for the first time in 1989 by Stephen De Felice, President of the Fundación para la Innovación en Medicine (Cranford, NJ, EE. UU. ). On the other hand, functional foods have additional effects due to the presence of components, generally non-nutritious, which interact selectively with one or more physiological functions of the organism (biomodulation) in such a way that an improvement in the state of health and well-being is evident. And/or a reduced risk of disease.
The Regulation EC / 178/2002 of the Parliament and the Council, 28/01/2002 establishes the general principles and requirements of food law, shows the European Food Safety Authority (EFSA), and establishes the procedures in the field of food safety.
Given their documented efficacy following the European Claims, which indicate for each substance what the individual uses may be (EFSA Journal 2011; 9 (4): 1984; EFSA Journal 2011; 9 (4): 2061; EFSA Journal 2012 ; 10 (3): 2604; EFSA Journal 2012; 10 (5): 2702; EFSA Journal 2016; 14 (1): 4367; EFSA Journal 2017; 15 (1): 4680; EFSA Journal 2018; 16 (1): 5136), a doubt related to safety in the general population remains today.
For this reason, in the month of March 2018, the Health and Quality of Life Working Group of the Italian Federation of Life Sciences (Fisv), which also includes the Italian Society of Pharmacology (Sif), the Italian Anthropological Association (Aai), Italian Agricultural Chemistry (Sica), Italian Society of Environmental Mutagenesis (Sima), Italian Society of General Microbiology and Microbial Biotechnology (Simgbm) and Italian Society of Plant Pathology (Sipav) has re-evaluated the scientific bibliography on the use of supplements or supplements food and has assessed that in the vast majority of cases their use is not only improper - as a good diet would be much more efficient to "heal" any deficiencies in trace elements or vitamins - but that often these products can cause undesirable effects, both for the concomitance of pathologies or pharmacological treatments with which they can interfere, both for the potential toxicity and oligopoly Minds and vitamins can exert on the body if their level of intake is higher than the needs of the moment. This is because many if not all of these supplements are authorized without having objective clinical safety data. Many of these are also used in poly-treated patients where interactions or adverse events may develop that are underestimated or unrecognized.
In consideration of the fact that the nutraceutical market is constantly growing (it is estimated 90 thousand products for over 30 billion dollars in turnover only in the US and 3 in Italy.), The need arises to evaluate "real life" in a manner objective to the possible efficacy and safety of nutraceuticals and functional foods used to treat systemic or local diseases.
- Conditions
- Systemic Disease, Skin Diseases, Memory Disorders, Urologic Diseases, Gastrointestinal Diseases, Inflammatory Disease
- Being tested
- nutraceuticals
- Keywords
- systemic diseases, topic diseases, nutrients
- Medical subject headings
- Skin Diseases, Memory Disorders, Urologic Diseases, Gastrointestinal Diseases, Acute Pain, Chronic Pain, Communicable Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutraceuticalsDietary supplement
antioxidants
| Study group | Role | What they receive |
|---|---|---|
| nutraceuticals and neurological disorders | evaluation of nutraceuticals in subjects with memory disorders Receives: Dietary Supplement: nutraceuticals | |
| nutraceuticals and skin disorders | evaluation of nutraceuticals in clinical conditions requiring topical treatment for skin diseases Receives: Dietary Supplement: nutraceuticals | |
| nutraceuticals and gastrointestinal diseases | evaluation of nutraceuticals in clinical conditions requiring systemic treatment for gastrointestinal diseases Receives: Dietary Supplement: nutraceuticals | |
| nutraceuticals and urological diseases | evaluation of nutraceuticals in the management of patients with prostate diseases or with lower tract infectious diseases requiring systemic or local treatment Receives: Dietary Supplement: nutraceuticals | |
| nutraceuticals and immunomediate diseases | evaluation of nutraceuticals in the management of patients with immunomediate disorders Receives: Dietary Supplement: nutraceuticals | |
| nutraceuticals and pain | evaluation of nutraceuticals in the management of patients with acute or chronic pain Receives: Dietary Supplement: nutraceuticals |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of memory
Mini-mental state examination: range from 0 (worst) to 30 (no deficit) (< 18 severe deficit, 19-24 mild deficit, >25 normal function)
Measured: 6 months
improvement of pain
Visual analogical scale: range from 0 (no pain) to 10 (high pain) > 8 severe pain; 4-7 moderate pain; 1-3 mild pain)
Measured: 6 months
Secondary outcomes (2)
change in plasma lipid values
LDL (mg/dL), HDL (mg/dL), total cholesterol (mg/dL)
Measured: 12 months
improvement of quality of life
36-Item Short Form Health Survey (SF-36), range from 0 (worst) to 100 (best)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start12 Nov 2019
- Primary completion29 Nov 2021
- Study completion29 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro, Azienda Ospedaliera Universitaria Policlinico, Azienda Ospedaliera Pugliese Ciaccio, Annunziata Hospital, Cosenza, Italy
- Responsible party
- Principal investigator, Luca Gallelli, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509075
- Sponsor's protocol ID
- Nutraceuticals
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaccaro MG, Innocenti B, Cione E, Gallelli L, De Sarro G, Bonilla DA, Cannataro R. Acute effects of a chewable beetroot-based supplement on cognitive performance: a double-blind randomized placebo-controlled crossover clinical trial. Eur J Nutr. 2024 Feb;63(1):303-321. doi: 10.1007/s00394-023-03265-y. Epub 2023 Oct 24.
PubMed 37875637
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Dell'Efficacia e Della Sicurezza Dei Nutraceutici Utilizzati Nella Popolazione Generale Per il Trattamento di Patologie Sistemiche o Locali
- ClinicalTrials.gov ID
- NCT05509075
- Acronym / sponsor ID
- Nutraceuticals
- Conditions
- Systemic Disease, Skin Diseases, Memory Disorders, Urologic Diseases, Gastrointestinal Diseases, Inflammatory Disease
- Keywords
- systemic diseases, topic diseases, nutrients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro, Azienda Ospedaliera Universitaria Policlinico, Azienda Ospedaliera Pugliese Ciaccio, Annunziata Hospital, Cosenza, Italy
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2023 (estimated)
- First posted
- 19 Aug 2022 (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.
Supplements and functional foods are now readily available and usable by the general population. Many supplemnets are commonly used in poly-treated patients where interactions or adverse events may develop, therefore we evaluate in the rela life the use of nutraceuticals, their clinical effects and the development of adverse drug reactions
Detailed description
Supplements (also called nutraceuticals because they derive from natural substances) and functional foods are now readily available and usable by the general population. The term "nutraceutical" derives from a fusion of the terms "nutritional" and "pharmaceutical" y was used for the first time in 1989 by Stephen De Felice, President of the Fundación para la Innovación en Medicine (Cranford, NJ, EE. UU. ). On the other hand, functional foods have additional effects due to the presence of components, generally non-nutritious, which interact selectively with one or more physiological functions of the organism (biomodulation) in such a way that an improvement in the state of health and well-being is evident. And/or a reduced risk of disease.
The Regulation EC / 178/2002 of the Parliament and the Council, 28/01/2002 establishes the general principles and requirements of food law, shows the European Food Safety Authority (EFSA), and establishes the procedures in the field of food safety.
Given their documented efficacy following the European Claims, which indicate for each substance what the individual uses may be (EFSA Journal 2011; 9 (4): 1984; EFSA Journal 2011; 9 (4): 2061; EFSA Journal 2012 ; 10 (3): 2604; EFSA Journal 2012; 10 (5): 2702; EFSA Journal 2016; 14 (1): 4367; EFSA Journal 2017; 15 (1): 4680; EFSA Journal 2018; 16 (1): 5136), a doubt related to safety in the general population remains today.
For this reason, in the month of March 2018, the Health and Quality of Life Working Group of the Italian Federation of Life Sciences (Fisv), which also includes the Italian Society of Pharmacology (Sif), the Italian Anthropological Association (Aai), Italian Agricultural Chemistry (Sica), Italian Society of Environmental Mutagenesis (Sima), Italian Society of General Microbiology and Microbial Biotechnology (Simgbm) and Italian Society of Plant Pathology (Sipav) has re-evaluated the scientific bibliography on the use of supplements or supplements food and has assessed that in the vast majority of cases their use is not only improper - as a good diet would be much more efficient to "heal" any deficiencies in trace elements or vitamins - but that often these products can cause undesirable effects, both for the concomitance of pathologies or pharmacological treatments with which they can interfere, both for the potential toxicity and oligopoly Minds and vitamins can exert on the body if their level of intake is higher than the needs of the moment. This is because many if not all of these supplements are authorized without having objective clinical safety data. Many of these are also used in poly-treated patients where interactions or adverse events may develop that are underestimated or unrecognized.
In consideration of the fact that the nutraceutical market is constantly growing (it is estimated 90 thousand products for over 30 billion dollars in turnover only in the US and 3 in Italy.), The need arises to evaluate "real life" in a manner objective to the possible efficacy and safety of nutraceuticals and functional foods used to treat systemic or local diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| nutraceuticals and neurological disorders | – | Dietary Supplement: nutraceuticalsevaluation of nutraceuticals in subjects with memory disorders |
| nutraceuticals and skin disorders | – | Dietary Supplement: nutraceuticalsevaluation of nutraceuticals in clinical conditions requiring topical treatment for skin diseases |
| nutraceuticals and gastrointestinal diseases | – | Dietary Supplement: nutraceuticalsevaluation of nutraceuticals in clinical conditions requiring systemic treatment for gastrointestinal diseases |
| nutraceuticals and urological diseases | – | Dietary Supplement: nutraceuticalsevaluation of nutraceuticals in the management of patients with prostate diseases or with lower tract infectious diseases requiring systemic or local treatment |
| nutraceuticals and immunomediate diseases | – | Dietary Supplement: nutraceuticalsevaluation of nutraceuticals in the management of patients with immunomediate disorders |
| nutraceuticals and pain | – | Dietary Supplement: nutraceuticalsevaluation of nutraceuticals in the management of patients with acute or chronic pain |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- At admission (T0), the anthropometric data and the functional clinical data of each patient (or healthy subject) will be collected. An aliquot of the blood sample will be used for transcriptomic evaluation. Immediately after the clinical and laboratory evaluation, each GP or each specialist will decide the type of nutraceutical or functional food to be used. For example, in elderly patient with osteoarthritis disorders can use a supplement based on chondroitin or glucosamine or other substances (or functional foods) with specific claims, as well as a patient with hypercholesterolemia without other risk factors can use a supplement containing monacolin K or flavonoids or other functional foods with claims specific. Similarly, patients with gastrointestinal or genitourinary disorders can use functional food based on probiotics or substances with a particular activity and comply with international claims.
Key inclusion criteria (2 listed)
- Patients or healthy subjects of both sexes and aged> 18 years Patients are not on supplement therapy or functional foods for any purpose.
- Patients who have given their consent to participate in the study
Key exclusion criteria (1 listed)
- Patients with severe renal or liver failure, neoplastic diseases or those with allergy to supplement or functional food , and those who do not sign the consent will be excluded from the study. Informed.
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 |
|---|---|---|
| nutraceuticalsantioxidants | Dietary supplement | nutraceuticals and gastrointestinal diseases, nutraceuticals and immunomediate diseases, nutraceuticals and neurological disorders, nutraceuticals and pain, nutraceuticals and skin disorders, nutraceuticals and urological diseases |
Primary outcome
improvement of memory
Time frame: 6 months
Mini-mental state examination: range from 0 (worst) to 30 (no deficit) (< 18 severe deficit, 19-24 mild deficit, >25 normal function)
improvement of pain
Time frame: 6 months
Visual analogical scale: range from 0 (no pain) to 10 (high pain) > 8 severe pain; 4-7 moderate pain; 1-3 mild pain)
2 secondary outcomes
change in plasma lipid values
Time frame: 12 months
improvement of quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Derived from this study: PubMed 37875637Vaccaro MG, Innocenti B, Cione E, Gallelli L, De Sarro G, Bonilla DA, Cannataro R. Acute effects of a chewable beetroot-based supplement on cognitive performance: a double-blind randomized placebo-controlled crossover clinical trial. Eur J Nutr. 2024 Feb;63(1):303-321. doi: 10.1007/s00394-023-03265-y. Epub 2023 Oct 24.
- Individual participant dataSharing planned: No
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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.
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 Systemic Disease and Skin Diseases, run by University of Catanzaro 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Gallelli, MD (+390961712322, gallelli@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of memory (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT05509075, which also lists 1 linked publication.
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 23 Aug 2022.