HypercholesterolemiaNCT06403748
Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels
A study testing Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients. in people with Hypercholesterolemia and Inflammation, run by University of Bologna at 1 site in Italy.
Trial summary
The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a food supplement is able to significantly influence… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Inflammation
- What is being tested?
- Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2024to 11 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects will have to meet all the following inclusion criteria:
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- 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.
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
Who cannot join
- Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:
- 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 for at least 3 months;
- Anticoagulant therapy
Show all 16Show fewer
- Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
- Known current thyroid, gastrointestinal or hepatobiliary diseases;
- Any medical or surgical condition that would limit the participant 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 diseases 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 or to one of these plant species: Asteraceae or Compositae;
- Women in fertile age not using consolidated contraceptive methods
- Pregnancy and Breastfeeding.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Bologna
Bologna, BO, 40138
Claudio Borghi, MD, 051 2142848 ext. +39, claudio.borghi@unibo.it
Arrigo F. Cicero, MD, arrigo.cicero@unibo.it
About this study
Official title: Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo-controlled, Randomized, Clinical Trial
The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.
- Conditions
- Hypercholesterolemia, Inflammation
- Being tested
- Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients., Placebo
- Medical subject headings
- Hypercholesterolemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients.Dietary supplement
The study will be conducted in male and female subjects, at least 18 and less than 70 years of age, with suboptimal level of LDL-Cholesterol (LDL 115-190 mg/dL) randomized into two groups to receive a preconstituted food supplement (NUT) combination containing (Red yeast rice 160 mg + Berberis aristate 449,7 mg + Folic acid 200 μg and others) in combination with a standard Mediterranean diet at low cholesterol content (<200 mg/day) (Standard of Care - SOC) [group 1], or a PLACEBO in combination with hypo-cholesterol diet (healthy Mediterranean diet following the indication of the European Atherosclerosis Society guidelines) [group 2].
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Active comparator | Not described Receives: Dietary Supplement: Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients. |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the dietary supplement on LDL-C at 6-week follow-up
The primary objective is to compare the effect on LDL-C after 6 weeks of treatment with a combined food supplement compared to placebo (standard diet only).
Measured: 6 weeks
Effect of the dietary supplement on LDL-C at 6-week follow-up
The primary objective is to compare the effect on LDL-C after 12 weeks of treatment with a combined food supplement compared to placebo (standard diet only).
Measured: 12 weeks
Secondary outcomes (12)
Effect of the dietary supplement on lipid fractions
Evaluate the effect of the tested combined food supplement intake on changes in other lipid fractions
Measured: 12 weeks
Effect of the dietary supplement on apolipoproteins
Evaluate the effect of the tested combined food supplement intake on changes in apolipoproteins
Measured: 12 weeks
Effect of the dietary supplement on hsCRP
Evaluate the effect of the tested combined food supplement intake on hsCRP levels
Measured: 12 weeks
Effect of the dietary supplement on indexes of NAFLD
Evaluate the effect of the tested combined food supplement intake on validated indexes of non-alcoholic fatty liver disease
Measured: 12 weeks
Effect of the dietary supplement on waist circumference
Evaluate the effect of the tested food supplement intake on changes in waist circumference. Waist circumference will be measured in a horizontal plane at the end of a normal expiration, at the midpoint between the inferior margin of the last rib and the superior iliac crest.
Measured: 12 weeks
Effect of the dietary supplement on weight
Evaluate the effect of the tested food supplement intake on changes in weight. Weight will be measured to the nearest 0.1 Kg.
Measured: 12 weeks
Effect of the dietary supplement on blood pressure
Evaluate the effect of the tested food supplement intake on changes in systolic blood pressure and diastolic blood pressure
Measured: 12 weeks
Effect of the dietary supplement on creatininemia
Evaluate the effect of the tested food supplement intake on changes in creatininemia
Measured: 12 weeks
Effect of the dietary supplement on eGFR
Evaluate the effect of the tested food supplement intake on renal function, evaluated as eGFR
Measured: 12 weeks
Effect of the dietary supplement on CPK levels
Evaluate the effect of the tested food supplement intake on changes in the blood levels of CPK
Measured: 12 weeks
Tolerability of the dietary supplement
Comparative evaluation of the short-term tolerability of the tested food supplement. Tolerability will be evaluated through a continuous monitoring during the study, to detect any adverse event, clinical safety, laboratory findings, vital sign measurements, and physical examinations
Measured: 12 weeks
Acceptability of the dietary supplement
Comparative evaluation of the short-term acceptability of the tested food. Acceptability will be evaluated by the use of a 10-point hedonic scale, where 1 = Disliked extremely and 9 = Liked extremely.
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 posted8 May 2024
- Study start6 May 2024 (estimated)
- Primary completion11 Oct 2024 (estimated)
- Study completion11 Oct 2024 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403748
- Sponsor's protocol ID
- NUT1-BO-2022
- Status last verified
- May 2024
- First submitted
- 9 Mar 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 May 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 a Combined Food Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo-controlled, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT06403748
- Acronym / sponsor ID
- NUT1-BO-2022
- Conditions
- Hypercholesterolemia, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 11 Oct 2024 (estimated)
- Study completion
- 11 Oct 2024 (estimated)
- First posted
- 8 May 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.
The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.
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 |
|---|---|---|
| Dietary supplement | Active comparator | Dietary Supplement: Dietary supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients. |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects agree to participate in the study and having dated and signed the informed consent form.
- 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.
Key exclusion criteria (16 listed)
- Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:
- 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 for at least 3 months;
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 supplement formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients.The study will be conducted in male and female subjects, at least 18 and less than 70 years of age, with suboptimal level of LDL-Cholesterol (LDL 115-190 mg/dL) randomized into two groups to receive a preconstituted food supplement (NUT) combination containing (Red yeast rice 160 mg + Berberis aristate 449,7 mg + Folic acid 200 μg and others) in combination with a standard Mediterranean diet at low cholesterol content (<200 mg/day) (Standard of Care - SOC) [group 1], or a PLACEBO in combination with hypo-cholesterol diet (healthy Mediterranean diet following the indication of the European Atherosclerosis Society guidelines) [group 2]. | Dietary supplement | Dietary supplement |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Effect of the dietary supplement on LDL-C at 6-week follow-up
Time frame: 6 weeks
The primary objective is to compare the effect on LDL-C after 6 weeks of treatment with a combined food supplement compared to placebo (standard diet only).
Effect of the dietary supplement on LDL-C at 6-week follow-up
Time frame: 12 weeks
The primary objective is to compare the effect on LDL-C after 12 weeks of treatment with a combined food supplement compared to placebo (standard diet only).
12 secondary outcomes
Effect of the dietary supplement on lipid fractions
Time frame: 12 weeks
Effect of the dietary supplement on apolipoproteins
Time frame: 12 weeks
Effect of the dietary supplement on hsCRP
Time frame: 12 weeks
Effect of the dietary supplement on indexes of NAFLD
Time frame: 12 weeks
Effect of the dietary supplement on waist circumference
Time frame: 12 weeks
Effect of the dietary supplement on weight
Time frame: 12 weeks
Effect of the dietary supplement on blood pressure
Time frame: 12 weeks
Effect of the dietary supplement on creatininemia
Time frame: 12 weeks
Effect of the dietary supplement on eGFR
Time frame: 12 weeks
Effect of the dietary supplement on CPK levels
Time frame: 12 weeks
Tolerability of the dietary supplement
Time frame: 12 weeks
Acceptability of the dietary supplement
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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.
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 formulated with components of natural origin: artichoke, danshen, bergamot, folic acid, chromium and excipients. in people with Hypercholesterolemia and Inflammation, 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 8 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the dietary supplement on LDL-C at 6-week follow-up (time frame: 6 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?
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 8 May 2024.