Nutraceuticals and Functional Foods

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509075
• Other study ID #: Nutraceuticals
• Status: Recruiting
• Start date: November 12, 2019
• Est. completion date: November 29, 2023

Study information

• Verified date: August 2022
• Source: University of Catanzaro
• Contact: Luca Gallelli, MD
• Phone: +390961712322
• Email: gallelli[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 adverse drug reactions

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2021
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• nutraceuticals
antioxidants

Locations

Country	Name	City	State
Italy	Luca Gallelli	Catanzaro

Sponsors (5)

Lead Sponsor	Collaborator
University of Catanzaro	Annunziata Hospital, Cosenza, Italy, Azienda Ospedaliera Pugliese Ciaccio, Azienda Ospedaliera Universitaria Policlinico, Azienda Sanitaria Provinciale Di Catanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Primary	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)	6 months
Secondary	change in plasma lipid values	LDL (mg/dL), HDL (mg/dL), total cholesterol (mg/dL)	12 months
Secondary	improvement of quality of life	36-Item Short Form Health Survey (SF-36), range from 0 (worst) to 100 (best)	6 months