Pharmacokinetic Study of Marine Active in Health Men

November 16, 2005 updated by: China Medical University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Kuo-Chin Huang, MD, Chinese-Western Medicine Cooperation, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 17, 2005

Last Update Submitted That Met QC Criteria

November 16, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMR94-IRB-68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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