Pharmacokinetic Study of Marine Active in Health Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by China Medical University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00207974
First received: September 16, 2005
Last updated: November 16, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Hyperuricemia, Anserine, Pharmacokinetic
Drug: Marine active
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by China Medical University Hospital:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00207974

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Kuo-Chin Huang, MD Chinese-Western Medicine Cooperation, China Medical University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00207974     History of Changes
Other Study ID Numbers: DMR94-IRB-68
Study First Received: September 16, 2005
Last Updated: November 16, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Hyperuricemia, Anserine, Pharmacokinetic

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014