DyslipidemiasNCT04161859
Use of Nutraceuticals in Clinical Practice
An observational study of Dyslipidemias and Diabetes Mellitus, Type 2, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemias, Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Nutraceutical
- How many people
- 387 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2017to 1 Mar 2021
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic, or hypertensive or dyslipidemic patients in primary and secondary prevention
Who may be able to join
- Diabetic patients in primary and secondary prevention or Hypertensive patients in primary and secondary prevention or Dyslipidemic patients in primary and secondary prevention
Who cannot join
- Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Use of the Nutraceutical With Cardio-metabolic Actions in the Patient in Primary and Secondary Prevention
The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.
Read the detailed description
The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. In particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).
- Conditions
- Dyslipidemias, Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Nutraceutical
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutraceuticalDietary supplement
Nutraceutical with action on glycemia, dsylipidemia or hypertension will be considered.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the use of nutraceutical in clinical practice
Prevalence
Measured: From 2010 to 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 May 2017
- Primary completion31 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161859
- Sponsor's protocol ID
- P-20160020534
- Status last verified
- May 2022
- First submitted
- 10 Nov 2019
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of the Nutraceutical With Cardio-metabolic Actions in the Patient in Primary and Secondary Prevention
- ClinicalTrials.gov ID
- NCT04161859
- Acronym / sponsor ID
- P-20160020534
- Conditions
- Dyslipidemias, Diabetes Mellitus, Type 2, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Nov 2019 (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 aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.
Detailed description
The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. In particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic, or hypertensive or dyslipidemic patients in primary and secondary prevention
Key inclusion criteria (1 listed)
- Diabetic patients in primary and secondary prevention or Hypertensive patients in primary and secondary prevention or Dyslipidemic patients in primary and secondary prevention
Key exclusion criteria (1 listed)
- Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
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 |
|---|---|---|
| NutraceuticalNutraceutical with action on glycemia, dsylipidemia or hypertension will be considered. | Dietary supplement | – |
Primary outcome
Prevalence of the use of nutraceutical in clinical practice
Time frame: From 2010 to 2015
Prevalence
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 24 May 2022.
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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?
An observational study of Dyslipidemias and Diabetes Mellitus, Type 2, run by University of 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 1 inclusion and 1 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 24 May 2022. 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. 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?
Prevalence of the use of nutraceutical in clinical practice (time frame: From 2010 to 2015). 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 24 May 2022.