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Crassostrea Gigas for Liver Health

NCT02992470 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2016-12-14

No results posted yet for this study

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.

Conditions

  • Nonalcoholic Fatty Liver

Interventions

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

Sponsors & Collaborators

  • Korean Medicine Hospital of Pusan National University

    lead OTHER

Principal Investigators

  • Jun-Yong Choi · Korean Medicine Hospital, Pusan National University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02992470 on ClinicalTrials.gov