Clinical Trial to Evaluate the Reduction of Cardiovascular Risk

Not Applicable

Completed

• Conditions: Cholesterol
• Interventions: Dietary Supplement: Apigenin, luteonin, grapefruit extract and citrolive; Dietary Supplement: maltodextrina

• Registration Number: NCT04114916
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2018-04-19
• Primary Completion: 2018-12-22
• Study Completion: 2018-12-30
• Status Verified: 2019-01
• Study First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Study First Posted: 2019-10-03
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apigenin, luteonin, grapefruit extract and citrolive	Apigenin, luteonin, grapefruit extract and citrolive	One capsules a day. It will be consumed at breakfast for eight weeks.
maltodextrina	maltodextrina	One capsules a day. It will be consumed at breakfast for eight weeks.

Primary Outcome Measures

Name	Time	Method
endothelial function	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.
blood samples	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.
Tests	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).
nutritional record	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.
body composition	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
cardiovascular risk	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).

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain