Nutraceutical on Hyperuricemia

Study Overview
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Brief Summary
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The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and < 7 mg/dl after 3 months of therapy.

Detailed Description
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The aim of this study will be to evaluate if a nutraceutical containing quercetin, rutin, bromelain and L-carnosine (Uricemin®) can reduce uric acid levels in subjects with values between ≥ 6 and < 7 mg/dl after 3 months of therapy. Patients will be randomized to Uricemin® or placebo for three months. We will evaluate body weight, fasting plasma glucose (FPG), lipid profile, uricemia (UA), high-sensitivity C-reactive protein (Hs-CRP) at baseline and after 3 months since the study start. Treatment tolerability will be assessed evaluating transaminases, and creatinine, and all adverse events will be recorded.

Official Title
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Evaluation of the Effects of a Supplement Composed by Quercetin, Rutin, Bromelain and L-carnosine in Patients With Hyperuricemia, a Randomized Clinical Trial

Conditions
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Hyperuricemia

Intervention / Treatment
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* Drug: Uricemin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with uric acid levels between ≥ 6 and < 7 mg/dl Patients not taking hypouricemic agents (both pharmaceuticals or nutraceutical agents) Exclusion Criteria: Patients with previous gout attack 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 history of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse. Patients taking (within the previous 3 months) hypouricemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, antidepressants, 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Uricemin<br> | Drug: Uricemin<br>* Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of Hyperuricemia | Uric acid levels | 3 months |