CClinicalTrials.gg
Sign In
CompletedNCT04506749JCUpdated Sep 29, 2020

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

An interventional study of Dietary supplement consumption in Cardiovascular Risk, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2019, registered Jul 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Cardiovascular Risk
03

In context

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Experimental group

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

    Dietary Supplement: Dietary supplement consumption

  • Placebo comparator
    control group Placebo

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

    Dietary Supplement: Dietary supplement consumption

Interventions

  • Dietary supplementDietary supplement consumption

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

06

What researchers measure

Primary outcomes

  1. Total Cholesterol

    Lipidic profile, measured in mg/dl

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

  2. LDL - Cholesterol

    Lipidic profile, measured in mg/dl

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

  3. HDL - Cholesterol

    Lipidic profile, measured in mg/dl

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

  4. Triglycerides

    Lipidic profile, measured in mg/dl

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

Secondary outcomes

  1. Assessing a change of blood pressure

    blood pressure is measured with a holter

    Time frame: 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

  2. Blood glucose

    Glycidic analysis, measured in mg/dL

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

  3. Glycosylated hemoglobin (HBA1c)

    Glycidic analysis, measured in %

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

  4. malondialdehyde (MDA)

    oxidative damage, measured in ng/ml

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

  5. Oxidized LDL

    oxidative damage, measured in pg/mL

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

  6. Superoxide Dismutase (SOD)

    antioxidant defense, measured in pg/mL

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

  7. Interleukin-6 (IL-6)

    Inflammation, measured in pg/mL

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

  8. Proteins C Reactive (PCR)

    Inflammation, measured in mg/l

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

  9. Fat mass

    Bioimpedance, in Kg.

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

  10. Muscle mass

    Bioimpedance, in Kg.

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

  11. Body mass index

    Bioimpedance, in Kg/m2.

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

  12. Percentage of fat mass

    Bioimpedance, in %.

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

  13. Control of dietary intake

    Diet source

    Time frame: 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.

  14. Physical Activity Questionnaire

    Measured with the questionnaire Global Questionnaire on Physical Activity

    Time frame: It is measured before and after the consumption time (56 days).

  15. 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)

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

07

Study locations

1 site
  • Catholic University of Murcia
    Murcia, 30107, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04506749
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Francisco Javier López Román (Principal Investigator, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Aug 10, 2020
Start date
Nov 11, 2019
Primary completion
Aug 14, 2020
Completion
Sep 18, 2020
Last update
Sep 29, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Universidad Católica San Antonio de Murcia

Start the discussion