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

NCT04506749 | Completed DMC

• 1 other identifier: UCAMCFE-00015
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk

Outcome Measures

Primary Outcomes (4)

• Total Cholesterol

  Lipidic profile, measured in mg/dl

  It is measured on an empty stomach, change after 56 days of consumption.

• LDL - Cholesterol

  Lipidic profile, measured in mg/dl

  It is measured on an empty stomach, change after 56 days of consumption.

• HDL - Cholesterol

  Lipidic profile, measured in mg/dl

  It is measured on an empty stomach, change after 56 days of consumption.

• Triglycerides

  Lipidic profile, measured in mg/dl

  It is measured on an empty stomach, change after 56 days of consumption.

Secondary Outcomes (15)

• Assessing a change of blood pressure

  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

• Blood glucose

  It is measured on an empty stomach, before and after the consumption time (56 days).

• Glycosylated hemoglobin (HBA1c)

  It is measured on an empty stomach, before and after the consumption time (56 days).

• malondialdehyde (MDA)

  It is measured on an empty stomach, before and after the consumption time (56 days).

• Oxidized LDL

  It is measured on an empty stomach, before and after the consumption time (56 days).

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Dietary Supplement: Dietary supplement consumption

control group Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Dietary supplement consumption

Interventions

Dietary supplement consumption DIETARY_SUPPLEMENT

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

Experimental group; control group Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 10, 2020
• Study Start: November 11, 2019
• Primary Completion: August 14, 2020
• Study Completion: September 18, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)