NCT02992470

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 12, 2016

Last Update Submit

December 12, 2016

Conditions

Nonalcoholic Fatty Liver

Outcome Measures

Primary Outcomes (1)

  • Change of serum alanine aminotransferase (ALT)

    Baseline, 4 weeks and 8 weeks

Secondary Outcomes (7)

  • 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

    Baseline, 4 weeks and 8 weeks

  • Change of serum bilirubin

    Baseline, 4 weeks and 8 weeks

  • Change of multi-dimensional fatigue inventory

    Baseline, 4 weeks and 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

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

Hydrolyzed oyster extractDIETARY_SUPPLEMENT

1 tablet of oyster extract t.i.d. for 8 weeks

Hydrolyzed oyster extract
PlaceboDIETARY_SUPPLEMENT

1 tablet of maltodextrin t.i.d. for 8 weeks

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Jun-Yong Choi

    Korean Medicine Hospital, Pusan National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun-Yong Choi, PhD, KMD

CONTACT

orientdoct@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 14, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Last Updated

December 14, 2016

Record last verified: 2016-12