NCT04161859

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

November 10, 2019

Last Update Submit

May 21, 2022

Conditions

DyslipidemiasDiabetes Mellitus, Type 2Hypertension

Outcome Measures

Primary Outcomes (1)

  • Prevalence of the use of nutraceutical in clinical practice

    Prevalence

    From 2010 to 2015

Interventions

NutraceuticalDIETARY_SUPPLEMENT

Nutraceutical with action on glycemia, dsylipidemia or hypertension will be considered.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

DyslipidemiasDiabetes Mellitus, Type 2Hypertension

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 13, 2019

Study Start

May 1, 2017

Primary Completion

December 31, 2020

Study Completion

March 1, 2021

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations

IT(1)