Nutraceutical on Hyperglycemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metabolic Actions of a Supplement of Ilex Paraguariensis, White Mulberry and Chromium Picolinate in Non-diabetic Subjects With Dysglycemia, a Randomized Clinical Trial

Conditions
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Dysglycemia

Intervention / Treatment
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* Dietary Supplement: Glicoset
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT) Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents) Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glicoset<br>Glicoset is a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate | Dietary Supplement: Glicoset<br>* Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Patients will take placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of dysglicemia | Oral glucose tolerance test | 3 months |