Health TrialsbyHealthPanel

Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism

ConditionsImpaired Fasting Glucose (IFG)Impaired Glucose Tolerance (Prediabetes)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • GlycoDual

    Dietary 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

  • Placebo

    Other intervention

    Placebo

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90 days

Secondary outcomes

1

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.

Time frame
90 days
2

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.

Time frame
90 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Policlinico San Matteo di Pavia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: