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

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: Completed
• Conditions: Cholesterol
• Intervention / Treatment: Dietary supplement: Apigenin, luteonin, grapefruit extract and citrolive; Dietary supplement: maltodextrina

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
endothelial function	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	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	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	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	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	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	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

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 22, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID 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