Cardiovascular RiskJCNCT04506749
To Evaluate the Efficacy of a Nutraceutical in Reducing Cardiovascular Risk in Healthy Subjects
A study testing Dietary supplement consumption in people with Cardiovascular Risk, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk
- What is being tested?
- Dietary supplement consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2019to 18 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects
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.
- Conditions
- Cardiovascular Risk
- Being tested
- Dietary supplement consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement consumptionDietary supplement
The consumption time was 56 days. Consumed 100 grams daily to consume during the day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Consumption of antioxidant boiled ham, 100 grams daily to consume during the day.
Consumption time: 8 weeks. Receives: 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. Receives: Dietary Supplement: Dietary supplement consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, change after 56 days of consumption.
LDL - Cholesterol
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, change after 56 days of consumption.
HDL - Cholesterol
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, change after 56 days of consumption.
Triglycerides
Lipidic profile, measured in mg/dl
Measured: It is measured on an empty stomach, change after 56 days of consumption.
Secondary outcomes (15)
Assessing a change of blood pressure
blood pressure is measured with a holter
Measured: 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
Glycidic analysis, measured in mg/dL
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Glycosylated hemoglobin (HBA1c)
Glycidic analysis, measured in %
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
malondialdehyde (MDA)
oxidative damage, measured in ng/ml
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Oxidized LDL
oxidative damage, measured in pg/mL
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Superoxide Dismutase (SOD)
antioxidant defense, measured in pg/mL
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Interleukin-6 (IL-6)
Inflammation, measured in pg/mL
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Proteins C Reactive (PCR)
Inflammation, measured in mg/l
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Fat mass
Bioimpedance, in Kg.
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Muscle mass
Bioimpedance, in Kg.
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Body mass index
Bioimpedance, in Kg/m2.
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Percentage of fat mass
Bioimpedance, in %.
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Control of dietary intake
Diet source
Measured: 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.
Physical Activity Questionnaire
Measured with the questionnaire Global Questionnaire on Physical Activity
Measured: It is measured before and after the consumption time (56 days).
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)
Measured: It is measured on an empty stomach, before and after the consumption time (56 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start11 Nov 2019
- Primary completion14 Aug 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506749
- Sponsor's protocol ID
- UCAMCFE-00015
- Acronym
- JC
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy of a Nutraceutical Versus Placebo in Reducing Cardiovascular Risk in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04506749
- Acronym / sponsor ID
- JC / UCAMCFE-00015
- Conditions
- Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Dietary supplement consumptionConsumption of antioxidant boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks. |
| control group Placebo | Placebo comparator | Dietary Supplement: Dietary supplement consumptionConsumption of extra boiled ham, 100 grams daily to consume during the day. Consumption time: 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplement consumptionThe consumption time was 56 days. Consumed 100 grams daily to consume during the day. | Dietary supplement | Experimental group, control group Placebo |
Primary outcome
Total Cholesterol
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
LDL - Cholesterol
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
HDL - Cholesterol
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
Triglycerides
Time frame: It is measured on an empty stomach, change after 56 days of consumption.
Lipidic profile, measured in mg/dl
15 secondary outcomes
Assessing a change of blood pressure
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
Blood glucose
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Glycosylated hemoglobin (HBA1c)
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
malondialdehyde (MDA)
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Oxidized LDL
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Superoxide Dismutase (SOD)
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Interleukin-6 (IL-6)
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Proteins C Reactive (PCR)
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Fat mass
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Muscle mass
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Body mass index
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Percentage of fat mass
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Control of dietary intake
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.
Physical Activity Questionnaire
Time frame: It is measured before and after the consumption time (56 days).
Liver safety variables
Time frame: It is measured on an empty stomach, before and after the consumption time (56 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement consumption in people with Cardiovascular Risk, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (time frame: It is measured on an empty stomach, change after 56 days of consumption.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.