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NCT04161859 Clinical Trial

Use of Nutraceuticals in Clinical Practice

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04161859
Other study ID # P-20160020534
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date March 1, 2021

Study information
Verified date May 2022
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 387
Est. completion date March 1, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Nutraceutical
Nutraceutical with action on glycemia, dsylipidemia or hypertension will be considered.

Locations
Country Name City State
Italy IRCCS Policlinico San Matteo Pavia Lombardy

Sponsors (1)
Lead Sponsor Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of the use of nutraceutical in clinical practice Prevalence From 2010 to 2015
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