Pharmacokinetic Study of Marine Active in Health Men

NCT ID: NCT00207974

Last Updated: 2005-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

Brief Summary

Hyperuricemia is often associated with metabolic syndrome, which is a known precursor of atherosclerosis. The Yaizu Suisankagaku Industry Company have developed industrial production, named Marine Active. Human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust to our hospital. This study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.

Detailed Description

Hyperuricemia is a common metabolic disorder. It can result from a decreased renal uric acid excretion, increased urate production, or both. The classical association with clinical gout is well-known. The principal indications for uric acid-lowering therapy, including allopurinol, probenecid and sulfinpyrazone, are the patients with gout history, macroscopic subcutaneous tophi, frequent attacks of gouty arthritis, or a documented state of uric acid overproduction. Hyperuricemia is often associated with metabolic syndrome,which is known a percursor of atherosclerosis. For the gout attack only 5% per year of the hyperuricemic population, medical management is not indicated for patients without gouty arthritis. Diet control is the leading way to control serum uric acid level, but usually it is not enough. So how to management hyperuricemia is important and is a potential management.Histidine-containing dipeptides such as Anserine and Carnosine have been studied extensively in recent years. These dipeptides were shown to be effective in acting as buffering agents against protons developed during anaerobic exercise. Anserine and Carnosine also have strong anti-oxidant activity, anti-cancer activity, immuno-response modulation, fat reduction and enhanced wound healing functions. The Yaizu Suisankagaku Industry Company have developed industrial production process to extract and purify the dipeptides from Bonito and Tuna. The extract, named Marine Active, was able to offer anti-fatigue activity by animal trial data. Human clinical trials showed reduction of creatine phosphokinase activity and sero-uric acid. Randomize, double blind clinical trial is entrust to our hospital. This study design is blood sampling from the health men who take 1 gm of marine active to analyse the pharmacokinetics of anserine.

Conditions

Hyperuricemia, Anserine, Pharmacokinetic

Keywords

Hyperuricemia, Anserine, Pharmacokinetic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Marine active

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-Male volunteers, age between 20 to 35 years

Exclusion Criteria

• Chronic medical history
• Significant liver or renal dysfunction,
• Have been administrated by any drug within 2 weeks before the initiation of study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Kuo-Chin Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese-Western Medicine Cooperation, China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

DMR94-IRB-68

Identifier Type: -

Identifier Source: org_study_id