Clinical Trial on the Effectiveness of Citrolive

NCT ID: NCT04330937

Last Updated: 2020-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-02-01

Brief Summary

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The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol.

Detailed Description

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The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol. To do this, volunteers consume the product under study or placebo for three months.

Tests will be performed before and after ingestion of the product.

Conditions

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Cardiovascular Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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experimental group

volunteers consume 1 capsule per day for 3 months. (500 mg citrolive).

Group Type EXPERIMENTAL

dietetics

Intervention Type DIETARY_SUPPLEMENT

90 days of consumption

control group Placebo (sucrose)

volunteers consume 1 capsule per day for 3 months. (saccharose).

Group Type PLACEBO_COMPARATOR

dietetics

Intervention Type DIETARY_SUPPLEMENT

90 days of consumption

Interventions

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dietetics

90 days of consumption

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Not belonging to the group of individuals considered as priorities by the Third Joint Task Force for the prevention of cardiovascular diseases due to high risk.
2. Present total cholesterol figures greater than 200 milligrams / deciliter and / or low density cholesterol figures greater than 130 milligrams / deciliter so that after applying the cardiovascular risk table (SCORE) they present a current risk of less than 5% of suffer an ischemic event in a period of 10 years, being without pharmacological treatment.
3. Present several cardiovascular risk factors with cholesterolemia figures close to 200 milligrams / deciliters and / or low density cholesterol figures close to 130 milligrams / deciliters.

Exclusion Criteria

1\. chronic or terminal illness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier López Román

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Murcia

Murcia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UCAMCFE-0008

Identifier Type: -

Identifier Source: org_study_id

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