HypercholesterolemiaANEMONENCT04574505
Food Supplementation With Eufortyn Colesterolo Plus for LDL Modulation in Subjects With Polygenic Hypercholesterolemia
A study testing Eufortyn Colesterolo Plus in people with Hypercholesterolemia, run by University of Bologna at 1 site in Italy.
Trial summary
This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy. The objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Eufortyn Colesterolo Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 14 Sep 2020to 19 Jan 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- Male or female aged ≥ 18 years and ≤ 70 years old.
- LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
- TG<400 mg/dL.
- Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to ESC/EAS guidelines 2019, the intervention strategy does not require a pharmacological lipid lowering intervention.
Who cannot join
- Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
- Obesity (BMI>30 kg/m2) or diabetes mellitus;
- Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- Antihypertensive treatment not stabilized since at least 3 months;
- Anticoagulants therapy
- Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
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- Known current thyroid, gastrointestinal or hepatobiliary diseases;
- Any medical or surgical condition that would limit the patient adhesion to the study protocol;
- Abuse of alcohol or drugs (current or previous);
- History of malignant neoplasia in the 5 years prior to enrolment in the study;
- History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
- History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- Known previous intolerance to one component of the tested nutraceuticals
- Women in fertile age not using consolidated contraceptive methods
- Pregnancy and Breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Food Supplementation With Eufortyn Colesterolo Plus on the Modulation of LDL Cholesterolemia in Subjects Affected by Polygenic Hypercholesterolemia: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.
This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
The objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara cardunculus) and Cynara scolimus, associated with high coenzyme Q10 bioavailability (Q10 phytosome® Ubiqsome) and zinc, on the glycometabolic structure of subjects with suboptimal levels of LDL cholesterolemia compared with placebo.
- Conditions
- Hypercholesterolemia
- Being tested
- Eufortyn Colesterolo Plus, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eufortyn Colesterolo PlusDietary supplement
Food supplement combination containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara Cardunculus L) and Cynara scolimus, associated with high coenzyme Q10 bioavailability(Q10 phytosome® Ubiqsome) and zinc.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NUT | Experimental | 1 tablet of Eufortyn Colesterolo Plus per day + standard diet for 8 weeks Receives: Dietary Supplement: Eufortyn Colesterolo Plus |
| Placebo | Placebo comparator | 1 tablet of Placebo per day + standard diet for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start14 Sep 2020
- Primary completion19 Nov 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Model description
- This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- SCHARPER Spa
- Responsible party
- Principal investigator, Arrigo F.G. Cicero, University of Bologna
- Investigators
- Arrigo Cicero, MD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574505
- Sponsor's protocol ID
- SCH 01/2020
- Acronym
- ANEMONE
- Status last verified
- Jan 2024
- First submitted
- 14 Sep 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fogacci F, Rizzoli E, Giovannini M, Bove M, D'Addato S, Borghi C, Cicero AFG. Effect of Dietary Supplementation with Eufortyn(R) Colesterolo Plus on Serum Lipids, Endothelial Reactivity, Indexes of Non-Alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study. Nutrients. 2022 May 18;14(10):2099. doi: 10.3390/nu14102099.
PubMed 35631240
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Food Supplementation With Eufortyn Colesterolo Plus on the Modulation of LDL Cholesterolemia in Subjects Affected by Polygenic Hypercholesterolemia: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.
- ClinicalTrials.gov ID
- NCT04574505
- Acronym / sponsor ID
- ANEMONE / SCH 01/2020
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- SCHARPER Spa
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 5 Oct 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.
This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
The objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara cardunculus) and Cynara scolimus, associated with high coenzyme Q10 bioavailability (Q10 phytosome® Ubiqsome) and zinc, on the glycometabolic structure of subjects with suboptimal levels of LDL cholesterolemia compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
| Arm | Type | Receives |
|---|---|---|
| NUT | Experimental | Dietary Supplement: Eufortyn Colesterolo Plus1 tablet of Eufortyn Colesterolo Plus per day + standard diet for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 tablet of Placebo per day + standard diet for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- Male or female aged ≥ 18 years and ≤ 70 years old.
- LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
- TG<400 mg/dL.
Key exclusion criteria (15 listed)
- Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
- Obesity (BMI>30 kg/m2) or diabetes mellitus;
- Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- Antihypertensive treatment not stabilized since at least 3 months;
- Anticoagulants therapy
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 |
|---|---|---|
| Eufortyn Colesterolo PlusFood supplement combination containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara Cardunculus L) and Cynara scolimus, associated with high coenzyme Q10 bioavailability(Q10 phytosome® Ubiqsome) and zinc. | Dietary supplement | NUT |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only).
Time frame: 8 weeks
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 1 Feb 2024.
- Results publication: PubMed 35631240Fogacci F, Rizzoli E, Giovannini M, Bove M, D'Addato S, Borghi C, Cicero AFG. Effect of Dietary Supplementation with Eufortyn(R) Colesterolo Plus on Serum Lipids, Endothelial Reactivity, Indexes of Non-Alcoholic Fatty Liver Disease and Systemic Inflammation in Healthy Subjects with Polygenic Hypercholesterolemia: The ANEMONE Study. Nutrients. 2022 May 18;14(10):2099. doi: 10.3390/nu14102099.
- 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.
Arrigo Cicero, MD principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eufortyn Colesterolo Plus in people with Hypercholesterolemia, run by University of Bologna at 1 site in Italy.
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 6 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 1 Feb 2024. 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 Italy. 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?
The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only). (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574505, which also lists 1 linked publication.
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 1 Feb 2024.