Use of Nutraceuticals in Clinical Practice

May 21, 2022 updated by: Giuseppe Derosa, University of Pavia

Observational Study on the Use of the Nutraceutical With Cardio-metabolic Actions in the Patient in Primary and Secondary Prevention

The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. In particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).

Study Type

Observational

Enrollment (Actual)

387

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Pavia, Lombardy, Italy, 27100
        • IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic, or hypertensive or dyslipidemic patients in primary and secondary prevention

Description

Inclusion Criteria:

Diabetic patients in primary and secondary prevention or Hypertensive patients in primary and secondary prevention or Dyslipidemic patients in primary and secondary prevention

Exclusion Criteria:

Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of the use of nutraceutical in clinical practice
Time Frame: From 2010 to 2015
Prevalence
From 2010 to 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 10, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 21, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-20160020534

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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