Clinical Trial to Evaluate the Reduction of Cardiovascular Risk (NUT)

October 1, 2019 updated by: Francisco Javier López Román, Universidad Católica San Antonio de Murcia

Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects.

Randomized parallel and double blind clinical trial in which it is intended to analyze the efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of a product for eight weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Spain
      • Murcia, Spain, 30107
        • Catholic University of Murcia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subjects of both sexes (men or women) between 40 and 75 years of age, of Caucasian race
  • Women must be in the menopausal period.
  • Present body mass index between 18.5 and 34.9 Kg / m2.
  • The number of platelets in whole blood must be greater than 170 x109 / L
  • Hematocrit greater than 40% for men or greater than 35% for women.
  • Hemoglobin greater than 120 g / L for men or 110 g / L for women.
  • Present fasting levels of LDL-serum cholesterol equal to or greater than 110mg / dL
  • Present fasting values of total serum cholesterol equal or superior to 180mg / dL
  • Volunteers able to understand the clinical study and willing to give written informed consent and to comply with the procedures and requirements of the study.

Exclusion Criteria:

  • Thyroid dysfunction, infections, or with any type of chronic disease (for example, autoimmune, inflammatory).
  • Subjects who have suffered an ischemic-vascular event during the last months
  • Subjects undergoing medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (eg Statins).
  • Subjects under treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...)
  • Subjects under treatment that affect body weight or appetite.
  • History of allergic hypersensitivity or poor tolerance to any component of the products under study.
  • Subjects who are performing or intend to perform any type of diet, hypocaloric or not, during the conduct of the study.
  • Subjects who have donated a minimum of 0.5L of blood in the last month.
  • Vegetarian subjects.
  • Subjects, who have ingested, in the last three months, supplements of omega 3 and / or 6, (eg fish oil, evening primrose oil, krill oil, or algae oil).
  • Subjects under treatment with niacin or fibrates.
  • Those subjects with alcohol abuse, or with excessive alcohol consumption (> 3 glasses of wine or beer / day) will be excluded.
  • Patients undergoing major surgery in the last 3 months.
  • Subjects who smoke or not, but in any case who do not modify their nicotinic habits during their participation in the study.
  • Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apigenin, luteonin, grapefruit extract and citrolive
One capsules a day. It will be consumed at breakfast for eight weeks.
Dietary supplement: Apigenin, luteonin, grapefruit extract and citrolive
Two capsules daily at breakfast and dinner.
Placebo Comparator: maltodextrina
One capsules a day. It will be consumed at breakfast for eight weeks.
Dietary supplement: maltodextrina
Two capsules daily at breakfast and dinner.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
endothelial function
Time Frame: The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after eight weeks of product consumption.
Changes in the dilatation of the Humeral artery.
The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after eight weeks of product consumption.
blood samples
Time Frame: Total cholesterol measurements are taken with the ILAB 600 analyzer on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Change in total cholesterol levels.
Total cholesterol measurements are taken with the ILAB 600 analyzer on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Tests
Time Frame: Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.
Change in physical activity with the World Physical Activity Questionnaire (GPAQ)
Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.
nutritional record
Time Frame: The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Volunteers record dietary intake for three days in a notebook. They will describe the amount of food they consume in grams in order to assess changes in intake during the clinical trial.
The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
body composition
Time Frame: Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Changes in body composition were measured with a TANITA
Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
cardiovascular risk
Time Frame: Cardiovascular risk measurements are taken by laboratory analysis on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Changes in systolic blood pressure (mmHg), dystolic blood pressure (mmHg) and heart rate (beats per minute).
Cardiovascular risk measurements are taken by laboratory analysis on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Tests
Time Frame: Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.
Change in the quality of life (SF-12).
Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica San Antonio de Murcia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCAMCFE-0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

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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