Crassostrea Gigas for Liver Health | NCT02992470

Studies
Crassostrea Gigas for Liver Health

NCT02992470

Sponsor

Korean Medicine Hospital of Pusan National University

Status

Unknown status

Last Update Posted

Dec 14, 2016Estimated

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Nonalcoholic Fatty Liver

Interventions

Hydrolyzed oyster extract
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Dec 12, 2016

First Posted Date

Dec 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2016

Last Update Posted Date

Dec 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrolyzed oyster extract	Experimental	A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract	Dietary Supplement: Hydrolyzed oyster extract
Placebo	Placebo Comparator	A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydrolyzed oyster extract	Dietary Supplement	1 tablet of oyster extract t.i.d. for 8 weeks	Hydrolyzed oyster extract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of serum alanine aminotransferase (ALT)		Baseline, 4 weeks and 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change of serum aspartate aminotransferase (AST)		Baseline, 4 weeks and 8 weeks
Change of gamma-glutamyl transferase (GGT)		Baseline, 4 weeks and 8 weeks
Rate of participants with normalized ALT, AST and GGT

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases