HypercholesterolemiaNCT04485793
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
A study testing Dietary supplement in people with Hypercholesterolemia, run by University of Bologna at 1 site in Italy.
Trial summary
The joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions", with use of drugs only if the LDL-C levels cannot be controlled with such lifestyle interventions. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 21 Sep 2020to 4 Oct 2021
- 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
- Healthy volunteers accepted
- 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 2012, 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 the tested nutraceutical
- 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 Dietary Supplement on Lipid Pattern and Liver Parameters in Moderately Hypercholesterolemic Subjects: a Double-blind, Placebo-controlled, Randomized, Clinical Trial
The joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions", with use of drugs only if the LDL-C levels cannot be controlled with such lifestyle interventions. "Lifestyle interventions" also includes food supplements. The reason is the following: a simple "dietary advice" has been shown (Cochrane review and meta-analysis, Rees et al, 2013) to achieve a modest reduction of total-C and LDL-C. The review reports: Dietary advice reduced total serum cholesterol by 0.15 mmol/L (95% CI 0.06 to 0.23) and LDL cholesterol by 0.16 mmol/L (95% CI 0.08 to 0.24) after 3 to 24 months." An average reduction of LDL-C by 0.16 mmol/L (6.2 mg/dL) is definitely insufficient to control the level of LDL-C in those subjects. Therefore, those subjects would lose motivation to keep dieting. In this context, use of supplements would significantly amplify the result of diet.
A significant proportion of ischemic cardiovascular events are believed to be supported by the coexistence of traditional cardiovascular risk factors such as diabetes, hypertension, dyslipidemia, smoking, and others. The aggregation of these factors is accompanied by a significant increase in the risk of cardiovascular events.
Read more
Observational studies shown the existence of a relationship between cholesterolemia and coronary heart disease, clearly showing that subjects with even modestly increased total cholesterol values over time develop both fatal and non-fatal vascular events with a higher frequency compared to subjects with similar characteristics, but with lower basal values of cholesterol.
Numerous controlled intervention studies, on the other hand, have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma concentration of total and LDL-C, obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in patients in secondary prevention.
- Conditions
- Hypercholesterolemia
- Being tested
- Dietary supplement, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary supplement
Dietary supplement formulated with 400 mg Bergamot d.e. obtained from different parts of the Citrus Bergamot whole fruit (Citrus bergamia Risso et Poiteau, fructus), specifically from fresh fruits collected from November to February (Brumex TM).
Oral administration: 1 tablet/day at evening meal
PlaceboOther
Oral administration: 1 tablet/day at evening meal
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Dietary supplement Receives: Dietary Supplement: Dietary supplement |
| Placebo comparator | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterolemia absolute reduction from baseline and between groups
Absolute reduction of LDL-cholesterolemia after 12 weeks of treatment
Measured: 12 weeks
LDL-cholesterolemia % reduction from baseline and between groups
% reduction of LDL-cholesterolemia after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (10)
Absolute reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios
Absolute reduction of serum concentrations of total cholesterol, HDL-cholesterol, apolipoprotein B, triglycerides and their ratios after 12 weeks of treatment
Measured: 12 weeks
% reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios
% reduction of of serum concentrations of total cholesterol, HDL-cholesterol, apolipoprotein B, triglycerides and their ratios after 12 weeks of treatment
Measured: 12 weeks
% reduction from baseline and between groups in anthropometric parameters
% reduction of body mass index after 12 weeks of treatment
Measured: 12 weeks
% reduction from baseline and between groups in blood pressure levels
% reduction of systolic and diastolic blood pressure after 12 weeks of treatment
Measured: 12 weeks
Absolute reduction from baseline and between groups in blood pressure levels
Absolute reduction of systolic and diastolic blood pressure after 12 weeks of treatment
Measured: 12 weeks
Absolute reduction from baseline and between groups in anthropometric parameters
Absolute reduction of body mass index after 12 weeks of treatment
Measured: 12 weeks
% reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels
% reduction of creatine phosphokinase (CPK) serum levels after 12 weeks of treatment
Measured: 12 weeks
Absolute reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels
Absolute reduction of creatine phosphokinase (CPK) serum levels after 12 weeks of treatment
Measured: 12 weeks
Absolute reduction from baseline and between groups in liver parameters
Absolute reduction of GOT, GPT and gamma-GT after 12 weeks of treatment
Measured: 12 weeks
% reduction from baseline and between groups in liver parameters
% reduction of GOT, GPT and gamma-GT after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start21 Sep 2020
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
- Investigators
- Claudio Borghi, MD, Principal investigator, S. Orsola-Malpighi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485793
- Sponsor's protocol ID
- NUT1-BO-2019
- Status last verified
- Jan 2024
- First submitted
- 21 Jul 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pierdomenico M, Cicero AFG, Veronesi M, Fogacci F, Riccioni C, Benassi B. Effect of Citrus bergamia extract on lipid profile: A combined in vitro and human study. Phytother Res. 2023 Sep;37(9):4185-4195. doi: 10.1002/ptr.7897. Epub 2023 Jun 13.
PubMed 37312672
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Moderately Hypercholesterolemic Subjects: a Double-blind, Placebo-controlled, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT04485793
- Acronym / sponsor ID
- NUT1-BO-2019
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 24 Jul 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 joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions", with use of drugs only if the LDL-C levels cannot be controlled with such lifestyle interventions. "Lifestyle interventions" also includes food supplements. The reason is the following: a simple "dietary advice" has been shown (Cochrane review and meta-analysis, Rees et al, 2013) to achieve a modest reduction of total-C and LDL-C. The review reports: Dietary advice reduced total serum cholesterol by 0.15 mmol/L (95% CI 0.06 to 0.23) and LDL cholesterol by 0.16 mmol/L (95% CI 0.08 to 0.24) after 3 to 24 months." An average reduction of LDL-C by 0.16 mmol/L (6.2 mg/dL) is definitely insufficient to control the level of LDL-C in those subjects. Therefore, those subjects would lose motivation to keep dieting. In this context, use of supplements would significantly amplify the result of diet.
A significant proportion of ischemic cardiovascular events are believed to be supported by the coexistence of traditional cardiovascular risk factors such as diabetes, hypertension, dyslipidemia, smoking, and others. The aggregation of these factors is accompanied by a significant increase in the risk of cardiovascular events.
Observational studies shown the existence of a relationship between cholesterolemia and coronary heart disease, clearly showing that subjects with even modestly increased total cholesterol values over time develop both fatal and non-fatal vascular events with a higher frequency compared to subjects with similar characteristics, but with lower basal values of cholesterol.
Numerous controlled intervention studies, on the other hand, have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma concentration of total and LDL-C, obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in patients in secondary prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Dietary Supplement: Dietary supplementDietary supplement |
| Placebo comparator | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| Dietary supplementDietary supplement formulated with 400 mg Bergamot d.e. obtained from different parts of the Citrus Bergamot whole fruit (Citrus bergamia Risso et Poiteau, fructus), specifically from fresh fruits collected from November to February (Brumex TM). Oral administration: 1 tablet/day at evening meal | Dietary supplement | Active Comparator |
| PlaceboOral administration: 1 tablet/day at evening meal | Other | Placebo comparator |
Primary outcome
LDL-cholesterolemia absolute reduction from baseline and between groups
Time frame: 12 weeks
Absolute reduction of LDL-cholesterolemia after 12 weeks of treatment
LDL-cholesterolemia % reduction from baseline and between groups
Time frame: 12 weeks
% reduction of LDL-cholesterolemia after 12 weeks of treatment
10 secondary outcomes
Absolute reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios
Time frame: 12 weeks
% reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios
Time frame: 12 weeks
% reduction from baseline and between groups in anthropometric parameters
Time frame: 12 weeks
% reduction from baseline and between groups in blood pressure levels
Time frame: 12 weeks
Absolute reduction from baseline and between groups in blood pressure levels
Time frame: 12 weeks
Absolute reduction from baseline and between groups in anthropometric parameters
Time frame: 12 weeks
% reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels
Time frame: 12 weeks
Absolute reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels
Time frame: 12 weeks
Absolute reduction from baseline and between groups in liver parameters
Time frame: 12 weeks
% reduction from baseline and between groups in liver parameters
Time frame: 12 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 31 Jan 2024.
- Results publication: PubMed 37312672Pierdomenico M, Cicero AFG, Veronesi M, Fogacci F, Riccioni C, Benassi B. Effect of Citrus bergamia extract on lipid profile: A combined in vitro and human study. Phytother Res. 2023 Sep;37(9):4185-4195. doi: 10.1002/ptr.7897. Epub 2023 Jun 13.
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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.
Claudio Borghi, MD principal investigator
S. Orsola-Malpighi University Hospital
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 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 31 Jan 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?
LDL-cholesterolemia absolute reduction from baseline and between groups (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT04485793, 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 31 Jan 2024.