CholesterolNUTNCT04114916
Clinical Trial to Evaluate the Reduction of Cardiovascular Risk
A study testing Apigenin, luteonin, grapefruit extract and citrolive and maltodextrina in people with Cholesterol, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized parallel and double blind clinical trial in which it is intended to analyze the efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of a product for eight weeks. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cholesterol
- What is being tested?
- Apigenin, luteonin, grapefruit extract and citrolive and maltodextrina
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2016to 30 Dec 2018
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects of both sexes (men or women) between 40 and 75 years of age, of Caucasian race
- Women must be in the menopausal period.
- Present body mass index between 18.5 and 34.9 Kg / m2.
- The number of platelets in whole blood must be greater than 170 x109 / L
- Hematocrit greater than 40% for men or greater than 35% for women.
- Hemoglobin greater than 120 g / L for men or 110 g / L for women.
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- Present fasting levels of LDL-serum cholesterol equal to or greater than 110mg / dL
- Present fasting values of total serum cholesterol equal or superior to 180mg / dL
- Volunteers able to understand the clinical study and willing to give written informed consent and to comply with the procedures and requirements of the study.
Who cannot join
- Thyroid dysfunction, infections, or with any type of chronic disease (for example, autoimmune, inflammatory).
- Subjects who have suffered an ischemic-vascular event during the last months
- Subjects undergoing medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (eg Statins).
- Subjects under treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...)
- Subjects under treatment that affect 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 performing or intend to perform any type of diet, hypocaloric or not, during the conduct of the study.
- Subjects who have donated a minimum of 0.5L of blood in the last month.
- Vegetarian subjects.
- Subjects, who have ingested, in the last three months, supplements of omega 3 and / or 6, (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) will be excluded.
- Patients undergoing major surgery in the last 3 months.
- Subjects who smoke or not, but in any case who do not modify 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.
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.
Randomized parallel and double blind clinical trial in which it is intended to analyze the efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of a product for eight weeks.
- Conditions
- Cholesterol
- Being tested
- Apigenin, luteonin, grapefruit extract and citrolive, maltodextrina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apigenin, luteonin, grapefruit extract and citroliveDietary supplement
Two capsules daily at breakfast and dinner.
maltodextrinaDietary supplement
Two capsules daily at breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Apigenin, luteonin, grapefruit extract and citrolive | Experimental | One capsules a day. It will be consumed at breakfast for eight weeks. Receives: Dietary Supplement: Apigenin, luteonin, grapefruit extract and citrolive |
| maltodextrina | Placebo comparator | One capsules a day. It will be consumed at breakfast for eight weeks. Receives: Dietary Supplement: maltodextrina |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
Changes in the dilatation of the Humeral artery.
Measured: The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after eight weeks of product consumption.
blood samples
Change in total cholesterol levels.
Measured: Total cholesterol measurements are taken with the ILAB 600 analyzer on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Tests
Change in physical activity with the World Physical Activity Questionnaire (GPAQ)
Measured: Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.
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: The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
body composition
Changes in body composition were measured with a TANITA
Measured: Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
cardiovascular risk
Changes in systolic blood pressure (mmHg), dystolic blood pressure (mmHg) and heart rate (beats per minute).
Measured: Cardiovascular risk measurements are taken by laboratory analysis on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Tests
Change in the quality of life (SF-12).
Measured: Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks 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 posted3 Oct 2019
- Study start1 Oct 2016
- Primary completion22 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesterolStudies 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
- 100 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
- NCT04114916
- Sponsor's protocol ID
- UCAMCFE-0005
- Acronym
- NUT
- Status last verified
- Jan 2019
- First submitted
- 19 Apr 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. 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
- NCT04114916
- Acronym / sponsor ID
- NUT / UCAMCFE-0005
- Conditions
- Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 3 Oct 2019 (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.
Randomized parallel and double blind clinical trial in which it is intended to analyze the efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of a product for eight weeks.
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 |
|---|---|---|
| Apigenin, luteonin, grapefruit extract and citrolive | Experimental | Dietary Supplement: Apigenin, luteonin, grapefruit extract and citroliveOne capsules a day. It will be consumed at breakfast for eight weeks. |
| maltodextrina | Placebo comparator | Dietary Supplement: maltodextrinaOne capsules a day. It will be consumed at breakfast for eight weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects of both sexes (men or women) between 40 and 75 years of age, of Caucasian race
- Women must be in the menopausal period.
- Present body mass index between 18.5 and 34.9 Kg / m2.
- The number of platelets in whole blood must be greater than 170 x109 / L
- Hematocrit greater than 40% for men or greater than 35% for women.
Key exclusion criteria (15 listed)
- Thyroid dysfunction, infections, or with any type of chronic disease (for example, autoimmune, inflammatory).
- Subjects who have suffered an ischemic-vascular event during the last months
- Subjects undergoing medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (eg Statins).
- Subjects under treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...)
- Subjects under treatment that affect 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 |
|---|---|---|
| Apigenin, luteonin, grapefruit extract and citroliveTwo capsules daily at breakfast and dinner. | Dietary supplement | Apigenin, luteonin, grapefruit extract and citrolive |
| maltodextrinaTwo capsules daily at breakfast and dinner. | Dietary supplement | maltodextrina |
Primary outcome
endothelial function
Time frame: The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after eight weeks of product consumption.
Changes in the dilatation of the Humeral artery.
blood samples
Time frame: Total cholesterol measurements are taken with the ILAB 600 analyzer on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Change in total cholesterol levels.
Tests
Time frame: Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.
Change in physical activity with the World Physical Activity Questionnaire (GPAQ)
nutritional record
Time frame: The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
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.
body composition
Time frame: Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Changes in body composition were measured with a TANITA
cardiovascular risk
Time frame: Cardiovascular risk measurements are taken by laboratory analysis on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product.
Changes in systolic blood pressure (mmHg), dystolic blood pressure (mmHg) and heart rate (beats per minute).
Tests
Time frame: Quality of life measurements are taken on two different occasions. Measurements are made at the beginning and after eight weeks of product consumption.
Change in the quality of life (SF-12).
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 3 Oct 2019.
- Individual participant dataSharing planned: Yes
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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 Apigenin, luteonin, grapefruit extract and citrolive and maltodextrina in people with Cholesterol, 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 9 inclusion and 15 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 3 Oct 2019. 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?
endothelial function (time frame: The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after eight weeks of product consumption.). The study lists 7 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 3 Oct 2019.