Nutraceuticals and Functional Foods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-12

Study Completion Date

2023-11-29

Brief Summary

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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

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Detailed Description

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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

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Systemic Disease Skin Diseases Memory Disorders Urologic Diseases Gastrointestinal Diseases Inflammatory Disease Pain, Acute Pain, Chronic Infective Disorder Immune System Diseases Immune Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No