To Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects (JC)

September 28, 2020 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

Single-blind, double-blind, controlled, randomized clinical trial of two parallel branches depending on the product consumed (experimental product and placebo product) and single-center with the objective of evaluating the effect of the investigational product on cardiovascular risk reduction.

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.

Detailed Description

Subjects who meet the selection criteria will make a total of two visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

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.
72

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects of both sexes (men or women) between 30 and 75 years of age, Caucasian.
  • Present body mass index between 20 and 32 Kg / m2.
  • Presenting fasting serum LDL-cholesterol levels equal to or greater than 110 mg / dL or total serum cholesterol equal to or greater than 180 mg / dL.
  • Volunteers capable of understanding the clinical study and willing to grant written informed consent and to comply with study procedures and requirements.

Exclusion Criteria:

  • Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
  • Subjects who have suffered an ischemic-vascular event in the last months.
  • Subjects in medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (ex: statins).
  • Subjects in treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...).
  • Subjects in treatment that affects body weight or appetite.
  • History of allergic hypersensitivity or poor tolerance to any component of the products under study.
  • Subjects who are carrying out or intend to carry out any type of diet, low-calorie or not, during the study.
  • Subjects who have donated a minimum of 0.5L of blood in the last month Vegetarian subjects.
  • Subjects who have ingested omega 3 and / or 6 supplements in the last three months, (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) were excluded.
  • Patients undergoing major surgery in the last 3 months.
  • Smoking subjects or not, but in any case who have changed 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.
  • Subjects whose condition did not make them eligible for the study according to the researcher's criteria.

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: Experimental group

Consumption of antioxidant boiled ham, 100 grams daily to consume during the day.

Consumption time: 8 weeks.
Dietary supplement: Dietary supplement consumption
The consumption time was 56 days. Consumed 100 grams daily to consume during the day.
Placebo Comparator: control group Placebo
Consumption of extra boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks.
Dietary supplement: Dietary supplement consumption
The consumption time was 56 days. Consumed 100 grams daily to consume during the day.

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
Total Cholesterol
Time Frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
It is measured on an empty stomach, change after 56 days of consumption.
LDL - Cholesterol
Time Frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
It is measured on an empty stomach, change after 56 days of consumption.
HDL - Cholesterol
Time Frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
It is measured on an empty stomach, change after 56 days of consumption.
Triglycerides
Time Frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
It is measured on an empty stomach, change after 56 days of consumption.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessing a change of blood pressure
Time Frame: Blood pressure measurements will be taken with a Holter monitor on two separate occasions and for 24 hours each day. Measurements were made at baseline and after 56 days of product consumption. Systolic and diastolic blood pressure will be measured
blood pressure is measured with a holter
Blood pressure measurements will be taken with a Holter monitor on two separate occasions and for 24 hours each day. Measurements were made at baseline and after 56 days of product consumption. Systolic and diastolic blood pressure will be measured
Blood glucose
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Glycidic analysis, measured in mg/dL
It is measured on an empty stomach, before and after the consumption time (56 days).
Glycosylated hemoglobin (HBA1c)
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Glycidic analysis, measured in %
It is measured on an empty stomach, before and after the consumption time (56 days).
malondialdehyde (MDA)
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
oxidative damage, measured in ng/ml
It is measured on an empty stomach, before and after the consumption time (56 days).
Oxidized LDL
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
oxidative damage, measured in pg/mL
It is measured on an empty stomach, before and after the consumption time (56 days).
Superoxide Dismutase (SOD)
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
antioxidant defense, measured in pg/mL
It is measured on an empty stomach, before and after the consumption time (56 days).
Interleukin-6 (IL-6)
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Inflammation, measured in pg/mL
It is measured on an empty stomach, before and after the consumption time (56 days).
Proteins C Reactive (PCR)
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Inflammation, measured in mg/l
It is measured on an empty stomach, before and after the consumption time (56 days).
Fat mass
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Bioimpedance, in Kg.
It is measured on an empty stomach, before and after the consumption time (56 days).
Muscle mass
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Bioimpedance, in Kg.
It is measured on an empty stomach, before and after the consumption time (56 days).
Body mass index
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Bioimpedance, in Kg/m2.
It is measured on an empty stomach, before and after the consumption time (56 days).
Percentage of fat mass
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Bioimpedance, in %.
It is measured on an empty stomach, before and after the consumption time (56 days).
Control of dietary intake
Time Frame: A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
Diet source
A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
Physical Activity Questionnaire
Time Frame: It is measured before and after the consumption time (56 days).
Measured with the questionnaire Global Questionnaire on Physical Activity
It is measured before and after the consumption time (56 days).
Liver safety variables
Time Frame: It is measured on an empty stomach, before and after the consumption time (56 days).
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
It is measured on an empty stomach, before and after the consumption time (56 days).

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.
November 11, 2019

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.
August 14, 2020

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.
September 18, 2020

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).
July 30, 2020

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.
August 6, 2020

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.
August 10, 2020

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.
September 29, 2020

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.
September 28, 2020

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.
July 1, 2020

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-00015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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