Nonalcoholic Fatty LiverNCT02992470
Crassostrea Gigas for Liver Health
A study testing Hydrolyzed oyster extract in people with Nonalcoholic Fatty Liver, run by Korean Medicine Hospital of Pusan National University.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver
- What is being tested?
- Hydrolyzed oyster extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
Jun-Yong Choi, PhD, KMD contact
About this study
Official title: Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial
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
- Being tested
- Hydrolyzed oyster extract, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed oyster extractDietary supplement
1 tablet of oyster extract t.i.d. for 8 weeks
PlaceboDietary supplement
1 tablet of maltodextrin t.i.d. for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hydrolyzed oyster extract | Experimental | A 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract Receives: Dietary Supplement: Hydrolyzed oyster extract |
| Placebo | Placebo comparator | A 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum alanine aminotransferase (ALT)
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (7)
Change of serum aspartate aminotransferase (AST)
Measured: Baseline, 4 weeks and 8 weeks
Change of gamma-glutamyl transferase (GGT)
Measured: Baseline, 4 weeks and 8 weeks
Rate of participants with normalized ALT, AST and GGT
Measured: Baseline, 4 weeks and 8 weeks
Change of serum bilirubin
Measured: Baseline, 4 weeks and 8 weeks
Change of multi-dimensional fatigue inventory
Measured: Baseline, 4 weeks and 8 weeks
Change of serum lipid profiles (triglyceride, total cholesterol, High-density lipoprotein and low-density lipoprotein cholesterol)
Measured: Baseline, 4 weeks and 8 weeks
Change of antioxidant enzymes (superoxide dismutase, malondialdehyde, glutathione peroxidase)
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Medicine Hospital of Pusan National University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun-Yong Choi, Principal investigator, Korean Medicine Hospital, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992470
- Sponsor's protocol ID
- 2016_11_Crassostrea gigas
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrolyzed Oyster Extract for Liver Health: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02992470
- Acronym / sponsor ID
- 2016_11_Crassostrea gigas
- Conditions
- Nonalcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolyzed oyster extract | Experimental | Dietary Supplement: Hydrolyzed oyster extractA 250 mg, film-coated oblong (rectangle) shaped tablet of oyster extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA 250 mg, film-coated oblong (rectangle) shaped tablet of maltodextrin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed oyster extract1 tablet of oyster extract t.i.d. for 8 weeks | Dietary supplement | Hydrolyzed oyster extract |
| Placebo1 tablet of maltodextrin t.i.d. for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Change of serum alanine aminotransferase (ALT)
Time frame: Baseline, 4 weeks and 8 weeks
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Yong Choi, PhD, KMD contact
Jun-Yong Choi principal investigator
Korean Medicine Hospital, Pusan National University
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed oyster extract in people with Nonalcoholic Fatty Liver, run by Korean Medicine Hospital of Pusan National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun-Yong Choi, PhD, KMD (orientdoct@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum alanine aminotransferase (ALT) (time frame: Baseline, 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.