Glucose Metabolism DisordersNCT05031715
Berberine and Altered Fasting Glucose
A study testing Berberine Phytosome in people with Glucose Metabolism Disorders, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
The aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Berberine Phytosome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2020to 25 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting blood glucose range:100-125 mg/dl
Who cannot join
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Mariangela Rondanelli
Pavia, 27100
Mariangela Rondanelli, 0382381749, mariangela.rondanelli@unipv.it
Mariangela Rondanelli, mariangela.rondanelli@unipv.it
About this study
Official title: Effectiveness of the Assumption of a Berberine Phytosoma-based Supplement on the Hematic Values of Glucose in a Group of Patients With Altered Fasting Glucose
The aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Berberine Phytosome
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine PhytosomeDietary supplement
2 tablets of 550 mg per day (1 before lunch and 1 before dinner)
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Experimental | Berberine Phytosome Receives: Dietary Supplement: Berberine Phytosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on insulin resistance
Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2,4
Measured: Changes from baseline insulin resistance at 4 weeks and at 8 weeks
Changes on carbohydrate profile
Fasting Glucose (mg/dl)
Measured: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Changes on carbohydrate profile
Glycated hemoglobin (%)
Measured: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Secondary outcomes (9)
Changes on anthropometry
Weight (Kg)
Measured: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on anthropometry
Body Mass Index (Kg/m2)
Measured: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on anthropometry
Waist circumference (cm)
Measured: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on body composition
Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)
Measured: Changes from baseline body composition at 4 weeks and at 8 weeks
Changes on lipid profile
Total Cholesterol (mg/dl), High density lipoprotein Cholesterol (mg/dl), Low density lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl), Apolipoprotein A (mg/dl), Apolipoprotein B (mg/dl)
Measured: Changes from baseline lipid profile at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Alanine aminotransferase (IU/l), Aspartate aminotransferase (IU/l)
Measured: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Gamma Glutamyl Transferase (U/l)
Measured: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Creatinine (mg/dl)
Measured: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Glomerural Filtrate Rate (ml/min)
Measured: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start2 Mar 2020
- Primary completion28 May 2020
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariangela Rondanelli, Principal investigator, Fondazione Casemiro Mondino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031715
- Sponsor's protocol ID
- ID 0912/14122018
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Assumption of a Berberine Phytosoma-based Supplement on the Hematic Values of Glucose in a Group of Patients With Altered Fasting Glucose
- ClinicalTrials.gov ID
- NCT05031715
- Acronym / sponsor ID
- ID 0912/14122018
- Conditions
- Glucose Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 2 Sep 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.
The aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Experimental | Dietary Supplement: Berberine PhytosomeBerberine Phytosome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fasting blood glucose range:100-125 mg/dl
Key exclusion criteria (1 listed)
- Diabetes mellitus
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 |
|---|---|---|
| Berberine Phytosome2 tablets of 550 mg per day (1 before lunch and 1 before dinner) | Dietary supplement | Dietary supplement |
Primary outcome
Changes on insulin resistance
Time frame: Changes from baseline insulin resistance at 4 weeks and at 8 weeks
Homeostasis Model Assessment (pt), for evaluate insulin resistance if > 2,4
Changes on carbohydrate profile
Time frame: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Fasting Glucose (mg/dl)
Changes on carbohydrate profile
Time frame: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Glycated hemoglobin (%)
9 secondary outcomes
Changes on anthropometry
Time frame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on anthropometry
Time frame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on anthropometry
Time frame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on body composition
Time frame: Changes from baseline body composition at 4 weeks and at 8 weeks
Changes on lipid profile
Time frame: Changes from baseline lipid profile at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.
Mariangela Rondanelli principal investigator
Fondazione Casemiro Mondino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine Phytosome in people with Glucose Metabolism Disorders, 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 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: status not confirmed, as of the sponsor's last update on 3 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariangela Rondanelli (+390382381749, mariangela.rondanelli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on insulin resistance (time frame: Changes from baseline insulin resistance at 4 weeks and at 8 weeks). The study lists 3 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 3 Mar 2022.