DysglycemiaPhase 3NCT04107922
Nutraceutical on Hyperglycemia
A Phase 3 study testing Glicoset in people with Dysglycemia, run by University of Pavia at 1 site in Italy.
Trial summary
The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dysglycemia
- What is being tested?
- Glicoset
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2018to 31 Aug 2019
- Phase
- Phase 3
- 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
Who may be able to join
- Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
- Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)
Who cannot join
- Patients with type 1 or type 2 diabetes mellitus
- Patients with impaired hepatic function
- Patient with impaired renal function
- Patients with gastrointestinal disorders
- Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
- Patients with weight change of > 3 Kg during the preceding 3 months
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- Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
- Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
- Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Actions of a Supplement of Ilex Paraguariensis, White Mulberry and Chromium Picolinate in Non-diabetic Subjects With Dysglycemia, a Randomized Clinical Trial
The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.
Read the detailed description
The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.
The investigators will enroll patients with impaired fasting plasma glucose (IFG) or impaired glucose tolerance (IGT), not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents). Patients will be randomized to take placebo or Glicoset® 1000 for 3 months, in a randomized, double-blind, placebo-controlled design. Glicoset® 1000 and placebo will be self-administered once a day, 1 tablet during the breakfast.
- Conditions
- Dysglycemia
- Being tested
- Glicoset, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlicosetDietary supplement
Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
PlaceboOther
Patients will take placebo
| Study group | Role | What they receive |
|---|---|---|
| Glicoset | Active comparator | Glicoset is a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate Receives: Dietary Supplement: Glicoset |
| 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.
Progression of dysglicemia
Oral glucose tolerance test
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 posted27 Sep 2019
- Study start1 Oct 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysglycemiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 148 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
- NCT04107922
- Sponsor's protocol ID
- P-20180016364
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 1 Oct 2019
- 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Actions of a Supplement of Ilex Paraguariensis, White Mulberry and Chromium Picolinate in Non-diabetic Subjects With Dysglycemia, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04107922
- Acronym / sponsor ID
- P-20180016364
- Conditions
- Dysglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 27 Sep 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 will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.
Detailed description
The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.
The investigators will enroll patients with impaired fasting plasma glucose (IFG) or impaired glucose tolerance (IGT), not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents). Patients will be randomized to take placebo or Glicoset® 1000 for 3 months, in a randomized, double-blind, placebo-controlled design. Glicoset® 1000 and placebo will be self-administered once a day, 1 tablet during the breakfast.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glicoset | Active comparator | Dietary Supplement: GlicosetGlicoset is a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
- Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)
Key exclusion criteria (9 listed)
- Patients with type 1 or type 2 diabetes mellitus
- Patients with impaired hepatic function
- Patient with impaired renal function
- Patients with gastrointestinal disorders
- Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
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 |
|---|---|---|
| GlicosetPatients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate | Dietary supplement | Glicoset |
| PlaceboPatients will take placebo | Other | Placebo |
Primary outcome
Progression of dysglicemia
Time frame: 3 months
Oral glucose tolerance test
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 Oct 2019.
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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 Phase 3 study testing Glicoset in people with Dysglycemia, 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 2 inclusion and 9 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 Oct 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Progression of dysglicemia (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 Oct 2019.