HyperlipidemiaNCT06692777
Evaluation of the Hypolipidemic Effect of Bergavit by a Human Trial.
A study testing Bergavit in people with Hyperlipidemia, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Bergavit is a product contains bergamot. Bergamot is an endemic plant of the Calabrian region in southern Italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Bergavit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Oct 2023to 31 Oct 2024
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1 Healthy men and women (40-70 years old);
- 2 Asian subjects with LDL-cholesterol (ranging from 100 to 159; see here below)
- 3 Subjects naïve to statins or other treatment and food supplement that can interfere with the study treatment for the previous 1 month
- 4 Reading, understanding and signed approval of the informative consent
- 5 No vegetarian. Subjects who will continue, expect reserve, their normal lifestyle
- 6 Healthy volunteers without clinical illness diagnosed with relevant effect on the gastrointestinal system or the motility visceral
Who cannot join
- 1 Subjects <40 and >70 years old
- 2 Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study
- 3 lack of compliance defined as not using the correct Bergavit dose or placebo for>1 week), and inability to give informed consent
- 4 Subjects who have changed their diet significantly or have been placed on weight reduction products
- 5 Smokers, Obesity subjects, during breast feeding
- 6 Changing the eating habits within the 2 weeks previous the screening
Show all 13Show fewer
- 7 During the pregnancy of the subjects or of the subjective planning of the study
- 8 Subjects with a history of drug, alcohol and other substance abuse
- 9 Known food intolerance or food allergy
- 10 Subjects involved in a clinical or food study within the previous month
- 11 Subjects who have unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
- 12 Subjects with a history of paralysis or cerebral vascular accident
- 13 Subjects with active cancers or on chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Bergavit is a product contains bergamot. Bergamot is an endemic plant of the Calabrian region in southern Italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through modulating enzymatic activities, anti-oxidation, anti-inflammatory mechanisms and inhibition of monocyte activation and proliferation.The primary outcome of the study the assessment of the the hypolipidemic effect of Bergavit. The secondary outcomes are the assessment of: a) the hypoglycemic effect of Bergavit, b) the activity of Bergavit on weight loss, and c) the hepatoprotective activity of Bergavit.
Read the detailed description
The study duration is 4 months. Subjects will attend clinic visits as follows:
- T0: First visit: assessment of all baseline parameters, Beginning of treatment
- T2: Second visit: assessment only of LDL level, Total cholesterol, ox-LDL, Triglycerides level, fasting glucose.
- T3: Third visit: assessment of all parameters.
- T4: Fourth visit: assessment of all parameters, end of the treatment.
- Conditions
- Hyperlipidemia
- Being tested
- Bergavit, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BergavitDietary supplement
Subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months.
PlaceboDietary supplement
Subjects will take capsule equivalent amount of maltodextrin for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Bergavit | Experimental | Group Bergavit : 60 subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months. Receives: Dietary Supplement: Bergavit |
| Placebo | Placebo comparator | Group Placebo: 60 subjects will take capsule equivalent amount of maltodextrin for 4 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Changes of LDL-C of the Subjects.
A randomized-double blind trial. The values change of LDL-C between before to after 0, 8, 12, 10 \& 16 weeks.
Measured: 16 weeks
Secondary outcomes (1)
The changes of Cholesterol of the Subjects.
A randomized-double blind trial. The values change of Cholesterol between before to after 0, 8, 12, 10 \& 16 weeks.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start21 Oct 2023
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, You-Cheng Shen, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692777
- Sponsor's protocol ID
- CS2-22083
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2024
- Last updated
- 18 Nov 2024
- 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 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hypolipidemic Effect of Bergavit by a Human Trial.
- ClinicalTrials.gov ID
- NCT06692777
- Acronym / sponsor ID
- CS2-22083
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 21 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 18 Nov 2024 (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.
Bergavit is a product contains bergamot. Bergamot is an endemic plant of the Calabrian region in southern Italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through modulating enzymatic activities, anti-oxidation, anti-inflammatory mechanisms and inhibition of monocyte activation and proliferation.The primary outcome of the study the assessment of the the hypolipidemic effect of Bergavit. The secondary outcomes are the assessment of: a) the hypoglycemic effect of Bergavit, b) the activity of Bergavit on weight loss, and c) the hepatoprotective activity of Bergavit.
Detailed description
The study duration is 4 months. Subjects will attend clinic visits as follows:
- T0: First visit: assessment of all baseline parameters, Beginning of treatment
- T2: Second visit: assessment only of LDL level, Total cholesterol, ox-LDL, Triglycerides level, fasting glucose.
- T3: Third visit: assessment of all parameters.
- T4: Fourth visit: assessment of all parameters, end of the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bergavit | Experimental | Dietary Supplement: BergavitGroup Bergavit : 60 subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboGroup Placebo: 60 subjects will take capsule equivalent amount of maltodextrin for 4 months. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1 Healthy men and women (40-70 years old);
- 2 Asian subjects with LDL-cholesterol (ranging from 100 to 159; see here below)
- 3 Subjects naïve to statins or other treatment and food supplement that can interfere with the study treatment for the previous 1 month
- 4 Reading, understanding and signed approval of the informative consent
- 5 No vegetarian. Subjects who will continue, expect reserve, their normal lifestyle
Key exclusion criteria (13 listed)
- 1 Subjects <40 and >70 years old
- 2 Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study
- 3 lack of compliance defined as not using the correct Bergavit dose or placebo for>1 week), and inability to give informed consent
- 4 Subjects who have changed their diet significantly or have been placed on weight reduction products
- 5 Smokers, Obesity subjects, during breast feeding
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 |
|---|---|---|
| BergavitSubjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months. | Dietary supplement | Bergavit |
| PlaceboSubjects will take capsule equivalent amount of maltodextrin for 4 months. | Dietary supplement | Placebo |
Primary outcome
The Changes of LDL-C of the Subjects.
Time frame: 16 weeks
A randomized-double blind trial. The values change of LDL-C between before to after 0, 8, 12, 10 \& 16 weeks.
1 secondary outcome
The changes of Cholesterol of the Subjects.
Time frame: 16 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 18 Nov 2024.
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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 Bergavit in people with Hyperlipidemia, run by Chung Shan Medical University at 1 site in Taiwan.
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 13 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 18 Nov 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 Taiwan. 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 Changes of LDL-C of the Subjects. (time frame: 16 weeks). 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 18 Nov 2024.