Nutraceuticals and Functional Foods

NCT05509075 | Unknown

• 1 other identifier: Nutraceuticals
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• change in plasma lipid values

  12 months

• improvement of quality of life

  6 months

Study Arms (6)

nutraceuticals and neurological disorders

evaluation of nutraceuticals in subjects with memory disorders

Dietary Supplement: nutraceuticals

nutraceuticals and skin disorders

evaluation of nutraceuticals in clinical conditions requiring topical treatment for skin diseases

Dietary Supplement: nutraceuticals

nutraceuticals and gastrointestinal diseases

evaluation of nutraceuticals in clinical conditions requiring systemic treatment for gastrointestinal diseases

Dietary Supplement: nutraceuticals

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

nutraceuticals and immunomediate diseases

evaluation of nutraceuticals in the management of patients with immunomediate disorders

Dietary Supplement: nutraceuticals

nutraceuticals and pain

evaluation of nutraceuticals in the management of patients with acute or chronic pain

Dietary Supplement: nutraceuticals

Interventions

nutraceuticals DIETARY_SUPPLEMENT

antioxidants

nutraceuticals and gastrointestinal diseases; nutraceuticals and immunomediate diseases; nutraceuticals and neurological disorders; nutraceuticals and pain; nutraceuticals and skin disorders; nutraceuticals and urological diseases

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Catanzaro: lead
• Azienda Sanitaria Provinciale Di Catanzaro: collaborator
• Azienda Ospedaliera Universitaria Policlinico: collaborator
• Azienda Ospedaliera Pugliese Ciaccio: collaborator
• Annunziata Hospital, Cosenza, Italy: collaborator

Study Sites (1)

Luca Gallelli

Catanzaro, 88100, Italy

RECRUITING

Related Publications (1)

• Vaccaro MG, Innocenti B, Cione E, Gallelli L, De Sarro G, Bonilla DA, Cannataro R. Acute effects of a chewable beetroot-based supplement on cognitive performance: a double-blind randomized placebo-controlled crossover clinical trial. Eur J Nutr. 2024 Feb;63(1):303-321. doi: 10.1007/s00394-023-03265-y. Epub 2023 Oct 24.

  PMID: 37875637 DERIVED

MeSH Terms

Conditions

Skin Diseases; Memory Disorders; Urologic Diseases; Gastrointestinal Diseases; Acute Pain; Chronic Pain; Communicable Diseases; Immune System Diseases

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Digestive System Diseases; Pain; Infections; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Luca Gallelli, MD

CONTACT

+390961712322; gallelli@unicz.it

Luca Gallelli

CONTACT

+390961712322; gallelli@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: November 12, 2019
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2023
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)