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Trial record 15 of 82 for:    extract | maltodextrin

Crassostrea Gigas for Liver Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992470
Recruitment Status : Unknown
Verified December 2016 by Korean Medicine Hospital of Pusan National University.
Recruitment status was:  Not yet recruiting
First Posted : December 14, 2016
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Korean Medicine Hospital of Pusan National University

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date December 14, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Change of serum alanine aminotransferase (ALT) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • Change of serum aspartate aminotransferase (AST) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  • Change of gamma-glutamyl transferase (GGT) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  • Rate of participants with normalized ALT, AST and GGT [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  • Change of serum bilirubin [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  • Change of multi-dimensional fatigue inventory [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  • Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  • Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crassostrea Gigas for Liver Health
Official Title  ICMJE Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial
Brief Summary This study aimed to observe whether a hydrolyzed oyster extract improves liver health in participants whose alanine transaminase (ALT) levels are1-3 fold above the normal. A total of 96 participants will be randomly allocated to active (oyster) or placebo group (1:1). Each group will receive 750 mg of oyster extract or placebo per day for 8 weeks. Primary outcome will be the change in ALT level and secondary outcomes will be; (1) ratios of participants with normal ALT, aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT); (2) the change in serum bilirubin; (3) the change in multi-dimensional fatigue inventory; (4) the changes in serum lipids; (5) the changes in antioxidant enzymes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Nonalcoholic Fatty Liver
Intervention  ICMJE
  • Dietary Supplement: Hydrolyzed oyster extract
    1 tablet of oyster extract t.i.d. for 8 weeks
  • Dietary Supplement: Placebo
    1 tablet of maltodextrin t.i.d. for 8 weeks
Study Arms  ICMJE
  • Experimental: Hydrolyzed oyster extract
    A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract
    Intervention: Dietary Supplement: Hydrolyzed oyster extract
  • Placebo Comparator: Placebo
    A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
96
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age over 19
  • AST, ALT, and GGT levels above the upper limit of the normal but less than 3 times the upper limit of the normal
  • Participants with normal physical activity who sign an informed consent form
  • Fatty liver detected by ultrasound

Exclusion Criteria:

  • Allergic reaction to oyster
  • Uncontrolled diabetes mellitus
  • Active viral hepatitis and any liver diseases that can affect trial outcomes (positive for HBs Ag or HCV Ab)
  • Liver cirrhosis of Child-Pugh class B or C
  • Chemotherapy or radiation therapy for cancer within 6 months
  • Cholelithiasis
  • Systemic medications that can affect liver function such as INH, valproic acid, tetracycline, allopurinol, phenytoin, phenelzine, sertraline, naproxen and diclofenac within 4 weeks
  • Medication of cholagogues, cholelitholytics & hepatic protectors, antidotes, detoxifying agents, and drug abuse (drugs used in substance dependence) within 4 weeks
  • Alcoholism or excessive alcohol intake of more than 168 g/week in men and 112 g/week in women
  • Kidney diseases or serum creatinine level above 2.0 mg/dL
  • Uncontrolled hypertension or angina pectoris or myocardiac infarction
  • History of bowel resection (not including surgery on simple appendicitis)
  • Medication of antipsychotic drugs
  • Herbal medication within 2 months
  • Pregnancy or breastfeeding
  • Participation of other clinical trial(s) within 1 months from screening day
  • Uncooperativeness
  • Intake of dietary supplements within 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02992470
Other Study ID Numbers  ICMJE 2016_11_Crassostrea gigas
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Korean Medicine Hospital of Pusan National University
Study Sponsor  ICMJE Korean Medicine Hospital of Pusan National University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jun-Yong Choi Korean Medicine Hospital, Pusan National University
PRS Account Korean Medicine Hospital of Pusan National University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP