Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism (NCT07263802) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism
90 participantsStarted 2025-12-01
Plain-language 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.
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.
Who can participate
Age range
35 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effects on glycemia
Timeframe: 90 days
Trial details
NCT IDNCT07263802
SponsorFondazione IRCCS Policlinico San Matteo di Pavia