HypercholesterolemiaNCT04697121
Artichoke and Bergamot Phytosome
A study testing Combined Bergamot phytosome and Artichoke leaf dry extract in people with Hypercholesterolemia, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Combined Bergamot phytosome and Artichoke leaf dry extract
- 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
- 21 Feb 2019to 16 Jul 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
- mild hypercholesterolemia (220 - 280 mg/dl)
- subjects were not taking any medication likely to affect lipid metabolism (such as statins)
- subjects were bergamot poor-responders
Who cannot join
- liver, renal and thyroid diseases
- history of cardiovascular disease (CVD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artichoke and Bergamot Phytosome: a Randomized Double Blind Clinical Trial in Bergamot Poor-responders
According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. The aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled trial. Participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).
- Conditions
- Hypercholesterolemia
- Being tested
- Combined Bergamot phytosome and Artichoke leaf dry extract, Placebo
- Keywords
- bergamot, Cynara cardunculus
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Bergamot phytosome and Artichoke leaf dry extractDietary supplement
600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract. Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
PlaceboCombination product
Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
| Combined Bergamot Phytosome and Artichoke leaf dry extract | Active comparator | 600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract Receives: Dietary Supplement: Combined Bergamot phytosome and Artichoke leaf dry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of lipid parameters
Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)
Measured: Baseline / 30 days / 60 days
Secondary outcomes (9)
Changes of lipid parameters
apolipoprotein A, apolipoprotein B, triglycerides (mg/dl)
Measured: Baseline / 30 days / 60 days
Changes of metabolic parameters
Fasting blood glucose (mg/dl)
Measured: Baseline / 30 days / 60 days
Changes of metabolic parameters
Glycated Hemoglobin (percent)
Measured: Baseline / 30 days / 60 days
Changes of anthropometric measurements
Weight (kg) and height (m) were combined to report BMI in kg/m^2
Measured: Baseline / 30 days / 60 days
Changes of anthropometric measurements
waist circumference (cm)
Measured: Baseline / 30 days / 60 days
Changes of body composition
Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)
Measured: Baseline / 30 days / 60 days
Changes of safety parameters
Aspartate Aminotransferase (UI/l), Alanine Aminotransferase (UI/l)
Measured: Baseline / 30 days / 60 days
Changes of safety parameters
Gamma Glutamyl Transferase (U/l)
Measured: Baseline / 30 days / 60 days
Changes of safety parameters
Creatinine (mg/dl)
Measured: Baseline / 30 days / 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start21 Feb 2019
- Primary completion2 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697121
- Sponsor's protocol ID
- 0921/22052019
- Status last verified
- Jan 2021
- First submitted
- 29 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artichoke and Bergamot Phytosome: a Randomized Double Blind Clinical Trial in Bergamot Poor-responders
- ClinicalTrials.gov ID
- NCT04697121
- Acronym / sponsor ID
- 0921/22052019
- Conditions
- Hypercholesterolemia
- Keywords
- bergamot, Cynara cardunculus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 6 Jan 2021 (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.
According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. The aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled trial. Participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Combination Product: Placebo |
| Combined Bergamot Phytosome and Artichoke leaf dry extract | Active comparator | Dietary Supplement: Combined Bergamot phytosome and Artichoke leaf dry extract600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild hypercholesterolemia (220 - 280 mg/dl)
- subjects were not taking any medication likely to affect lipid metabolism (such as statins)
- subjects were bergamot poor-responders
Key exclusion criteria (2 listed)
- liver, renal and thyroid diseases
- history of cardiovascular disease (CVD)
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 |
|---|---|---|
| Combined Bergamot phytosome and Artichoke leaf dry extract600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract. Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks. | Dietary supplement | Combined Bergamot Phytosome and Artichoke leaf dry extract |
| PlaceboSupplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks. | Combination product | Placebo |
Primary outcome
Changes of lipid parameters
Time frame: Baseline / 30 days / 60 days
Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)
9 secondary outcomes
Changes of lipid parameters
Time frame: Baseline / 30 days / 60 days
Changes of metabolic parameters
Time frame: Baseline / 30 days / 60 days
Changes of metabolic parameters
Time frame: Baseline / 30 days / 60 days
Changes of anthropometric measurements
Time frame: Baseline / 30 days / 60 days
Changes of anthropometric measurements
Time frame: Baseline / 30 days / 60 days
Changes of body composition
Time frame: Baseline / 30 days / 60 days
Changes of safety parameters
Time frame: Baseline / 30 days / 60 days
Changes of safety parameters
Time frame: Baseline / 30 days / 60 days
Changes of safety parameters
Time frame: Baseline / 30 days / 60 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 6 Jan 2021.
- 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 Combined Bergamot phytosome and Artichoke leaf dry extract in people with Hypercholesterolemia, run by Azienda di Servizi alla Persona di Pavia 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 3 inclusion and 2 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 6 Jan 2021. 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?
Changes of lipid parameters (time frame: Baseline / 30 days / 60 days). 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 6 Jan 2021.