Impaired Fasting Glucose (IFG)NCT07263802
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism
A study testing GlycoDual in people with Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (Prediabetes), run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial summary
The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (Prediabetes)
- What is being tested?
- GlycoDual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index (BMI) 25.0-29.9 kg/m2
- FPG levels between 100 and 125 mg/dl [IFG diagnosed after Oral Glucose Tolerance Test (OGTT)]
- HOMA-IR > 2.5
- subjects able to understand the informed consent and sign it before enrollment in the study
Who cannot join
- personal history of cardiovascular disease or equivalent risk factors
- obesity (BMI ≥ 30 kg/m²)
- taking hypoglycemic drugs or supplements that affect glycemic metabolism
- diabetes mellitus or IGT
- pregnancy or breastfeeding
- known thyroid, liver, kidney or muscle diseases
- any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent
- any known allergy or hypersensitivity to one or more components of the food supplement
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy of GlycoDual on Postprandial Glycemic Control and Insulin Sensitivity in Subjects With Impaired Glucose Metabolism: a Randomized, Controlled, Double-blind Study
The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
- the change of insulin sensitivity (HOMA-IR)
- the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
Read the detailed description
Mild dysglycemias, such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), represent pre-diabetic conditions characterized by a subclinical impairment of insulin sensitivity and β-cell function. Early intervention in this phase can prevent or delay the progression to full-blown diabetes. In this context, the use of nutraceutical supplements with physiological activity on glucose metabolism represents a promising and well-tolerated approach, able to effectively modulate metabolic parameters, with a good safety profile. GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
- the change of insulin sensitivity (HOMA-IR)
- the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
- Being tested
- GlycoDual, Placebo
- Keywords
- dysglycemia, Gymnema sylvestre, Zinc bisglycinate
- Medical subject headings
- Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycoDualDietary supplement
GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Patients taking nutraceutical Receives: Dietary Supplement: GlycoDual |
| Placebo | Placebo comparator | Patients taking placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on glycemia
evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Measured: 90 days
Secondary outcomes (2)
Change in Insulin sensitivity
The secondary objective will be to evaluate the efficacy of GlycoDual in reducing insulin sensitivity (HOMA-IR) levels compared to placebo after 90 days of treatment.
Measured: 90 days
Change in uricemia
The secondary objective will be to evaluate the efficacy of GlycoDual in reducing uricemia levels compared to placebo after 90 days of treatment.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Fasting Glucose (IFG)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263802
- Sponsor's protocol ID
- GDUAL-2025-RCT01
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of GlycoDual on Postprandial Glycemic Control and Insulin Sensitivity in Subjects With Impaired Glucose Metabolism: a Randomized, Controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT07263802
- Acronym / sponsor ID
- GDUAL-2025-RCT01
- Keywords
- dysglycemia, Gymnema sylvestre, Zinc bisglycinate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 4 Dec 2025 (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 objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
- the change of insulin sensitivity (HOMA-IR)
- the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
Detailed description
Mild dysglycemias, such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), represent pre-diabetic conditions characterized by a subclinical impairment of insulin sensitivity and β-cell function. Early intervention in this phase can prevent or delay the progression to full-blown diabetes. In this context, the use of nutraceutical supplements with physiological activity on glucose metabolism represents a promising and well-tolerated approach, able to effectively modulate metabolic parameters, with a good safety profile. GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
- the change of insulin sensitivity (HOMA-IR)
- the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: GlycoDualPatients taking nutraceutical |
| Placebo | Placebo comparator | Other: PlaceboPatients taking placebo |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- body mass index (BMI) 25.0-29.9 kg/m2
- FPG levels between 100 and 125 mg/dl [IFG diagnosed after Oral Glucose Tolerance Test (OGTT)]
- HOMA-IR > 2.5
- subjects able to understand the informed consent and sign it before enrollment in the study
Key exclusion criteria (8 listed)
- personal history of cardiovascular disease or equivalent risk factors
- obesity (BMI ≥ 30 kg/m²)
- taking hypoglycemic drugs or supplements that affect glycemic metabolism
- diabetes mellitus or IGT
- pregnancy or breastfeeding
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 |
|---|---|---|
| GlycoDualGlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia | Dietary supplement | Intervention |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Effects on glycemia
Time frame: 90 days
evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
2 secondary outcomes
Change in Insulin sensitivity
Time frame: 90 days
Change in uricemia
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Growth Hormone Resistance of Beta-cells
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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.
Questions about this trial
What is this clinical trial studying?
A study testing GlycoDual in people with Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (Prediabetes), run by Fondazione IRCCS Policlinico San Matteo di Pavia.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Derosa, MD (+390382502614, g.derosa@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on glycemia (time frame: 90 days). 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 4 Dec 2025.