Hyperuricemia
Conditions
Brief summary
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
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.
Interventions
DRUGUricemin
Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine
DRUGPlacebo
Placebo
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of Hyperuricemia | 3 months | Uric acid levels |
Countries
Italy
Outcome results
None listed