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Trial record 15 of 82 for:    extract | maltodextrin

Crassostrea Gigas for Liver Health

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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

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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Dietary Supplement: Hydrolyzed oyster extract Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017


Arm Intervention/treatment
Experimental: Hydrolyzed oyster extract
A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract
Dietary Supplement: Hydrolyzed oyster extract
1 tablet of oyster extract t.i.d. for 8 weeks

Placebo Comparator: Placebo
A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin
Dietary Supplement: Placebo
1 tablet of maltodextrin t.i.d. for 8 weeks




Primary Outcome Measures :
  1. Change of serum alanine aminotransferase (ALT) [ Time Frame: Baseline, 4 weeks and 8 weeks ]

Secondary Outcome Measures :
  1. Change of serum aspartate aminotransferase (AST) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  2. Change of gamma-glutamyl transferase (GGT) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  3. Rate of participants with normalized ALT, AST and GGT [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  4. Change of serum bilirubin [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  5. Change of multi-dimensional fatigue inventory [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  6. Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol) [ Time Frame: Baseline, 4 weeks and 8 weeks ]
  7. Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase) [ Time Frame: Baseline, 4 weeks and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992470


Contacts
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Contact: Jun-Yong Choi, PhD, KMD orientdoct@gmail.com

Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Investigators
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Principal Investigator: Jun-Yong Choi Korean Medicine Hospital, Pusan National University

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Responsible Party: Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT02992470     History of Changes
Other Study ID Numbers: 2016_11_Crassostrea gigas
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases