Clinical trial NCT05509075: Nutraceuticals and Functional Foods
Official title: Valutazione Dell'Efficacia e Della Sicurezza Dei Nutraceutici Utilizzati Nella Popolazione Generale Per il Trattamento di Patologie Sistemiche o Locali
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Disease
Skin Diseases
Memory Disorders
Urologic Diseases
Gastrointestinal Diseases
Inflammatory Disease
Pain, Acute
Pain, Chronic
Infective Disorder
Immune System Diseases
Immune Defect
Keywords: systemic diseases
topic diseases
nutrients
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Provinciale Di Catanzaro
name: Azienda Ospedaliera Universitaria Policlinico
name: Azienda Ospedaliera Pugliese Ciaccio
name: Annunziata Hospital, Cosenza, Italy
First posted: 2022-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: improvement of memory
timeFrame: 6 months
measure: improvement of pain
timeFrame: 6 months
Secondary outcomes:
measure: change in plasma lipid values
timeFrame: 12 months
measure: improvement of quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Luca Gallelli
Study officials:
References: