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

NCT ID: NCT04506749

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2020-09-18

Brief Summary

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.

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.

Conditions

Cardiovascular Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

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

Consumption time: 8 weeks.

Group Type: EXPERIMENTAL

Dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

The consumption time was 56 days. Consumed 100 grams daily to consume during the day.

control group Placebo

Consumption of extra boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks.

Group Type: PLACEBO_COMPARATOR

Dietary supplement consumption

Intervention Type: DIETARY_SUPPLEMENT

The consumption time was 56 days. Consumed 100 grams daily to consume during the day.

Interventions

Dietary supplement consumption

The consumption time was 56 days. Consumed 100 grams daily to consume during the day.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Francisco Javier López Román

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catholic University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

UCAMCFE-00015

Identifier Type: -

Identifier Source: org_study_id