Nutraceuticals and Functional Foods

Sponsor

University of Catanzaro (Other)

Overall Status

Recruiting

CT.gov ID

NCT05509075

Collaborator

Azienda Sanitaria Provinciale Di Catanzaro (Other), Azienda Ospedaliera Universitaria Policlinico (Other), Azienda Ospedaliera Pugliese Ciaccio (Other), Annunziata Hospital, Cosenza, Italy (Other)

Enrollment

Location

48.6

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Disease Skin Diseases Memory Disorders Urologic Diseases Gastrointestinal Diseases Inflammatory Disease Pain, Acute Pain, Chronic Infective Disorder Immune System Diseases Immune Defect	Dietary Supplement: nutraceuticals

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

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Valutazione Dell'Efficacia e Della Sicurezza Dei Nutraceutici Utilizzati Nella Popolazione Generale Per il Trattamento di Patologie Sistemiche o Locali

Actual Study Start Date :

Nov 12, 2019

Actual Primary Completion Date :

Nov 29, 2021

Anticipated Study Completion Date :

Nov 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
nutraceuticals and neurological disorders evaluation of nutraceuticals in subjects with memory disorders	Dietary Supplement: nutraceuticals antioxidants
nutraceuticals and skin disorders evaluation of nutraceuticals in clinical conditions requiring topical treatment for skin diseases	Dietary Supplement: nutraceuticals antioxidants
nutraceuticals and gastrointestinal diseases evaluation of nutraceuticals in clinical conditions requiring systemic treatment for gastrointestinal diseases	Dietary Supplement: nutraceuticals antioxidants
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	Dietary Supplement: nutraceuticals antioxidants
nutraceuticals and immunomediate diseases evaluation of nutraceuticals in the management of patients with immunomediate disorders	Dietary Supplement: nutraceuticals antioxidants
nutraceuticals and pain evaluation of nutraceuticals in the management of patients with acute or chronic pain	Dietary Supplement: nutraceuticals antioxidants

Outcome Measures

Primary Outcome Measures

improvement of memory [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 [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)

Secondary Outcome Measures

change in plasma lipid values [12 months]
LDL (mg/dL), HDL (mg/dL), total cholesterol (mg/dL)
improvement of quality of life [6 months]
36-Item Short Form Health Survey (SF-36), range from 0 (worst) to 100 (best)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

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.