DyslipidemiaNCT03019263
Berberine, Chlorogenic Acid and Tocotrienols in Menopause-associated Dyslipidemia
A study testing Nutraceutical in people with Dyslipidemia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Nutraceutical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2017to 12 Jan 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- LDL cholesterol >100 mg/dL
- Written informed consent available
Who cannot join
- Use of any drug affecting blood lipids
- Hormone replacement therapy
- Adherence to a weigh loss diet in the previous 6 months
- Cancer diagnosis
- Known thyroid, liver, renal or muscle diseases
- Any medical or surgical condition which could lead to an inconstant adhesion to the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.
- Conditions
- Dyslipidemia
- Being tested
- Nutraceutical, Control
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutraceuticalDietary supplement
Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
ControlOther
Nutritional counseling
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical | Experimental | Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid Receives: Dietary Supplement: Nutraceutical |
| Control | Active comparator | Nutritional counseling Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
LDL cholesterol
Measured: 3 months
Secondary outcomes (10)
Insulin resistance
Homeostatic model assessment (HOMA index)
Measured: 3 months
Total cholesterol
Total cholesterol
Measured: 3 months
HDL cholesterol
HDL cholesterol
Measured: 3 months
Blood glucose
Blood glucose
Measured: 3 months
Serum Insulin
Serum Insulin
Measured: 3 months
Body weight
Body weight
Measured: 3 months
Fat distribution
Waist circumference
Measured: 3 months
Fat Mass
Fat Mass
Measured: 3 months
Menopausal symptoms
Greene Climacteric Scale
Measured: 3 months
Quality of life
36-Item Short Form Health Survey (SF-36)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start31 Mar 2017
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Riccardo Caccialanza, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019263
- Sponsor's protocol ID
- 20140012470
- Status last verified
- Apr 2025
- First submitted
- 10 Jan 2017
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutraceutical Intervention With Berberine, Chlorogenic Acid and Tocotrienols for Menopause-associated Dyslipidemia: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03019263
- Acronym / sponsor ID
- 20140012470
- Conditions
- Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 12 Jan 2017 (estimated)
- 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.
Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical | Experimental | Dietary Supplement: NutraceuticalNutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid |
| Control | Active comparator | Other: ControlNutritional counseling |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- LDL cholesterol >100 mg/dL
- Written informed consent available
Key exclusion criteria (6 listed)
- Use of any drug affecting blood lipids
- Hormone replacement therapy
- Adherence to a weigh loss diet in the previous 6 months
- Cancer diagnosis
- Known thyroid, liver, renal or muscle diseases
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 |
|---|---|---|
| NutraceuticalNutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid | Dietary supplement | Nutraceutical |
| ControlNutritional counseling | Other | Control |
Primary outcome
LDL cholesterol
Time frame: 3 months
LDL cholesterol
10 secondary outcomes
Insulin resistance
Time frame: 3 months
Total cholesterol
Time frame: 3 months
HDL cholesterol
Time frame: 3 months
Blood glucose
Time frame: 3 months
Serum Insulin
Time frame: 3 months
Body weight
Time frame: 3 months
Fat distribution
Time frame: 3 months
Fat Mass
Time frame: 3 months
Menopausal symptoms
Time frame: 3 months
Quality of life
Time frame: 3 months
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 1 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Nutraceutical in people with Dyslipidemia, run by Fondazione IRCCS Policlinico San Matteo 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 2 inclusion and 6 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 1 May 2025. 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?
LDL cholesterol (time frame: 3 months). 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 1 May 2025.