Clinical Trial to Evaluate the Reduction of Cardiovascular Risk

NCT ID: NCT04114916

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-12-30

Brief Summary

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.

Conditions

Cholesterol

Study Design

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

Study Groups

Apigenin, luteonin, grapefruit extract and citrolive

One capsules a day. It will be consumed at breakfast for eight weeks.

Group Type: EXPERIMENTAL

Apigenin, luteonin, grapefruit extract and citrolive

Intervention Type: DIETARY_SUPPLEMENT

Two capsules daily at breakfast and dinner.

maltodextrina

One capsules a day. It will be consumed at breakfast for eight weeks.

Group Type: PLACEBO_COMPARATOR

maltodextrina

Intervention Type: DIETARY_SUPPLEMENT

Two capsules daily at breakfast and dinner.

Interventions

Apigenin, luteonin, grapefruit extract and citrolive

Two capsules daily at breakfast and dinner.

Intervention Type: DIETARY_SUPPLEMENT

maltodextrina

Two capsules daily at breakfast and dinner.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• 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-0005

Identifier Type: -

Identifier Source: org_study_id