Nutraceuticals and Functional Foods

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

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Diseases; Skin Diseases; Immune System Diseases; Urologic Diseases; Pain, Acute; Pain, Chronic; Memory Disorders; Inflammatory Disease; Immune Defect; Systemic Disease; Infective Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Luca Gallelli; Phone Number: +390961712322; Email: gallelli@unicz.it

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • Luca Gallelli
    • Contact: Luca Gallelli, MD; Email: gallelli@unicz.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Catanzaro
• Collaborators: Azienda Ospedaliera Universitaria Policlinico; Azienda Sanitaria Provinciale Di Catanzaro; Annunziata Hospital, Cosenza, Italy; Azienda Ospedaliera Pugliese Ciaccio

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2019
• Primary Completion (ACTUAL): November 29, 2021
• Study Completion (ANTICIPATED): November 29, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (ACTUAL): August 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: systemic diseases; nutrients; topic diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Chronic Pain; Gastrointestinal Diseases; Digestive System Diseases; Acute Pain; Skin Diseases; Immune System Diseases; Memory Disorders; Urologic Diseases
• Other Study ID Numbers: Nutraceuticals

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No