Effect of a Food Supplement on Blood Glucose Levels in Patients With Impaired Glucose Values

ConditionDysglycemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

The primary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing FPG compared to baseline and to recommended standard diet alone after 3 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≤30 kg/m2

subjects able to understand the informed consent and sign it before enrollment in the study

subjects willing to follow all study requirements and perform all study visits as well as collaborate with the investigator.

Disqualifiers

ongoing treatment with drugs that can affect blood glucose

current participation in another investigational drug or investigational device trial or inclusion in another investigational drug or investigational device trial within the previous month

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nutraceutical supplements

    Dietary supplement

    An association of banaba leaves extract and chromium picolinate (Euglycem®) will be administered

  • Placebo

    Dietary supplement

    Placebo

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: EuglycemActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dysglicemia

The primary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing FPG compared to baseline and to recommended standard diet alone after 3 months of supplementation.

Time frame
3 months

Secondary outcomes

1

Insulin reistance

The secondary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing HbA1c, FPI and HOMA index

Time frame
3 months
2

Vitamin D3 levels

The secondary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on the variation of vitamin D3 levels

Time frame
3 months
3

Glycemic status

The secondary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on the proportion of subjects pass from impaired fasting glycemia (IFG) condition to euglycemia and the proportion of subjects pass from impaired glucose tolerance (IGT) condition to euglycemia

Time frame
3 months

Other outcomes

Sponsors and contacts

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