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

Cardiovascular Risk Clinical Trial

— JC  

Official title:

Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506749
• Other study ID #: UCAMCFE-00015
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: September 18, 2020

Study information

• Verified date: July 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 18, 2020
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk

Intervention

Dietary Supplement:
• Dietary supplement consumption
The consumption time was 56 days. Consumed 100 grams daily to consume during the day.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Cholesterol	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, change after 56 days of consumption.
Primary	LDL - Cholesterol	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, change after 56 days of consumption.
Primary	HDL - Cholesterol	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, change after 56 days of consumption.
Primary	Triglycerides	Lipidic profile, measured in mg/dl	It is measured on an empty stomach, change after 56 days of consumption.
Secondary	Assessing a change of blood pressure	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
Secondary	Blood glucose	Glycidic analysis, measured in mg/dL	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Glycosylated hemoglobin (HBA1c)	Glycidic analysis, measured in %	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	malondialdehyde (MDA)	oxidative damage, measured in ng/ml	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Oxidized LDL	oxidative damage, measured in pg/mL	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Superoxide Dismutase (SOD)	antioxidant defense, measured in pg/mL	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Interleukin-6 (IL-6)	Inflammation, measured in pg/mL	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Proteins C Reactive (PCR)	Inflammation, measured in mg/l	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Fat mass	Bioimpedance, in Kg.	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Muscle mass	Bioimpedance, in Kg.	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Body mass index	Bioimpedance, in Kg/m2.	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Percentage of fat mass	Bioimpedance, in %.	It is measured on an empty stomach, before and after the consumption time (56 days).
Secondary	Control of dietary intake	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.
Secondary	Physical Activity Questionnaire	Measured with the questionnaire Global Questionnaire on Physical Activity	It is measured before and after the consumption time (56 days).
Secondary	Liver safety variables	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).