Cardiovascular RiskCITROXINCT04330937
Clinical Trial on the Effectiveness of Citrolive
A study testing dietetics in people with Cardiovascular Risk, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol. 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?
- dietetics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 1 Feb 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
- Not belonging to the group of individuals considered as priorities by the Third Joint Task Force for the prevention of cardiovascular diseases due to high risk.
- Present total cholesterol figures greater than 200 milligrams / deciliter and / or low density cholesterol figures greater than 130 milligrams / deciliter so that after applying the cardiovascular risk table (SCORE) they present a current risk of less than 5% of suffer an ischemic event in a period of 10 years, being without pharmacological treatment.
- Present several cardiovascular risk factors with cholesterolemia figures close to 200 milligrams / deciliters and / or low density cholesterol figures close to 130 milligrams / deciliters.
Who cannot join
- 1. chronic or terminal illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on the Effectiveness of Citrolive® to Decrease Oxidation of Low Density Lipoproteins
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol.
Read the detailed description
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol. To do this, volunteers consume the product under study or placebo for three months.
Tests will be performed before and after ingestion of the product.
- Conditions
- Cardiovascular Risk
- Being tested
- dietetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dieteticsDietary supplement
90 days of consumption
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | volunteers consume 1 capsule per day for 3 months. (500 mg citrolive). Receives: Dietary Supplement: dietetics |
| control group Placebo (sucrose) | Placebo comparator | volunteers consume 1 capsule per day for 3 months. (saccharose). Receives: Dietary Supplement: dietetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
The systolic and diastolic blood pressure was measured with an OMRON oscilimétrilo sphygmomanometer
Measured: The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation
Biochemistry and blood count
the hematological profile is analyzed with the Horiba ABX Oentra 80 analyzer. Biochemical profile with the ILAB 600 analyzer
Measured: The change is observed after three months of intake of the product under investigation
Secondary outcomes (7)
Weight
Measured in Kg.
Measured: The change is observed after three months of intake of the product under investigation
Height
Measured in cm.
Measured: The change is observed after three months of intake of the product under investigation
BMI
Weight and height are combined for BMI report in kg / m ^ 2
Measured: The change is observed after three months of intake of the product under investigation
Perimeters
Measured in cm. Waist, hip, waist / hip index, relaxed biceps, contracted biceps, medial thigh, twin or calf.
Folds (mm) (tricipítal, subscapular, suprailiac anterior or supraspinal, abdominal, quadricipital or thigh, leg or calf medial, bicipital, iliocrestal).
Diameters (cm) (radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol).
Measured: The change is observed after three months of intake of the product under investigation
Folds
Measured in mm. Tricipítal, subscapular, suprailiac anterior or supraspinal, abdominal, quadricipital or thigh, leg or calf medial, bicipital, iliocrestal.
Diameters (cm) (radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol).
Measured: The change is observed after three months of intake of the product under investigation
Diameters
Measured in cm. Radiocubital or wrist biestiloid, humeral or elbow bicpicondiolo, femoral or knee bicondiol.
Measured: The change is observed after three months of intake of the product under investigation
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.
Measured: Measurements are made at the beginning and after 90 days of product consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Oct 2017
- Primary completion30 Nov 2019
- Study completion1 Feb 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
- 23 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
- NCT04330937
- Sponsor's protocol ID
- UCAMCFE-0008
- Acronym
- CITROXI
- Status last verified
- Mar 2020
- First submitted
- 16 Oct 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effectiveness of Citrolive® to Decrease Oxidation of Low Density Lipoproteins
- ClinicalTrials.gov ID
- NCT04330937
- Acronym / sponsor ID
- CITROXI / UCAMCFE-0008
- Conditions
- Cardiovascular Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 2 Apr 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.
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol.
Detailed description
The clinical trial consists in checking the antioxidant effect of citrolive on low density cholesterol. To do this, volunteers consume the product under study or placebo for three months.
Tests will be performed before and after ingestion of the product.
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: dieteticsvolunteers consume 1 capsule per day for 3 months. (500 mg citrolive). |
| control group Placebo (sucrose) | Placebo comparator | Dietary Supplement: dieteticsvolunteers consume 1 capsule per day for 3 months. (saccharose). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not belonging to the group of individuals considered as priorities by the Third Joint Task Force for the prevention of cardiovascular diseases due to high risk.
- Present total cholesterol figures greater than 200 milligrams / deciliter and / or low density cholesterol figures greater than 130 milligrams / deciliter so that after applying the cardiovascular risk table (SCORE) they present a current risk of less than 5% of suffer an ischemic event in a period of 10 years, being without pharmacological treatment.
- Present several cardiovascular risk factors with cholesterolemia figures close to 200 milligrams / deciliters and / or low density cholesterol figures close to 130 milligrams / deciliters.
Key exclusion criteria (1 listed)
- 1. chronic or terminal illness.
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 |
|---|---|---|
| dietetics90 days of consumption | Dietary supplement | control group Placebo (sucrose), experimental group |
Primary outcome
Blood pressure
Time frame: The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation
The systolic and diastolic blood pressure was measured with an OMRON oscilimétrilo sphygmomanometer
Biochemistry and blood count
Time frame: The change is observed after three months of intake of the product under investigation
the hematological profile is analyzed with the Horiba ABX Oentra 80 analyzer. Biochemical profile with the ILAB 600 analyzer
7 secondary outcomes
Weight
Time frame: The change is observed after three months of intake of the product under investigation
Height
Time frame: The change is observed after three months of intake of the product under investigation
BMI
Time frame: The change is observed after three months of intake of the product under investigation
Perimeters
Time frame: The change is observed after three months of intake of the product under investigation
Folds
Time frame: The change is observed after three months of intake of the product under investigation
Diameters
Time frame: The change is observed after three months of intake of the product under investigation
Nutritional record
Time frame: Measurements are made at the beginning and after 90 days of product consumption.
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 2 Apr 2020.
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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 dietetics 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 3 inclusion and 1 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 2 Apr 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?
Blood pressure (time frame: The change in systolic and diastolic blood pressure is observed after three months of intake of the product under investigation). The study lists 2 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 2 Apr 2020.