Nonalcoholic Fatty Liver DiseaseNCT01707914
Clinical Investigation on the Effects of Bayberry Juice Treatment in Adult Subjects With Features of Fatty Liver Disease
A study testing Chinese bayberry juice in people with Nonalcoholic Fatty Liver Disease, run by Shaoguan University at 1 site in China.
Trial summary
Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous animal studies from us and other investigators, anthocyanins have been shown to ameliorate dyslipidemia and hepatic steatosis in different… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- What is being tested?
- Chinese bayberry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Nov 2012
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject inclusion criteria were age 18-25 y,
- BMI [body weight divided by height squared (in kg/m2)] > 23,
- lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
- the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.
Who cannot join
- overuse of alcohol,
- viral hepatitis,
- type 1 or 2 diabetes,
- gastrointestinal or connective diseases,
- chronic pancreatitis,
- liver cirrhosis,
Show all 9Show fewer
- kidney stones, or renal failure;
- use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;
- supplementation with vitamins or antioxidants.
Trial locations and contacts
1 site in 1 country.
China1 site
The affiliated hospital of Shaoguan University
Shaoguan, Guangdong, 512005
About this study
Official title: Effects of Chinese Bayberry Juice on Liver Enzymes and Plasma Antioxidant Activity in Adult Subjects With Features of Fatty Liver Disease: a Randomised Placebo-controlled Trial
Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous animal studies from us and other investigators, anthocyanins have been shown to ameliorate dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on levels of biomarkers related to antioxidant status in young adults with features of fatty liver disease.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Being tested
- Chinese bayberry juice, placebo
- Keywords
- oxidative stress, dyslipidemia, inflammation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese bayberry juiceDietary supplement
Consume 500 mL CBJ/d (250 mL CBJ twice daily)
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Chinese bayberry juice | Experimental | Consume 500 mL CBJ/d (250 mL CBJ twice daily) Receives: Dietary Supplement: Chinese bayberry juice |
| Placebo | Placebo comparator | Consume 500 mL placebo/d (250 mL placebo twice daily) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipids profile
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaoguan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenyi Zhong, MD, Study director, Shaoguan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707914
- Sponsor's protocol ID
- SGU-01
- Other IDs
- 81172655
- Status last verified
- Dec 2012
- First submitted
- 14 Oct 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guo H, Zhong R, Liu Y, Jiang X, Tang X, Li Z, Xia M, Ling W. Effects of bayberry juice on inflammatory and apoptotic markers in young adults with features of non-alcoholic fatty liver disease. Nutrition. 2014 Feb;30(2):198-203. doi: 10.1016/j.nut.2013.07.023.
PubMed 24377455
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chinese Bayberry Juice on Liver Enzymes and Plasma Antioxidant Activity in Adult Subjects With Features of Fatty Liver Disease: a Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01707914
- Acronym / sponsor ID
- SGU-01
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- oxidative stress, dyslipidemia, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Shaoguan UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Oct 2012 (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.
Chinese bayberry, one of six Myrica species native to China, is rich in anthocyanins, and cyanidin-3-O-glucoside (C3G) was identified as a major anthocyanin component. In previous animal studies from us and other investigators, anthocyanins have been shown to ameliorate dyslipidemia and hepatic steatosis in different rodent models. The aim of the present study was to examine the effects of Chinese bayberry juice (CBJ) on the serum lipid profile and on levels of biomarkers related to antioxidant status in young adults with features of fatty liver disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese bayberry juice | Experimental | Dietary Supplement: Chinese bayberry juiceConsume 500 mL CBJ/d (250 mL CBJ twice daily) |
| Placebo | Placebo comparator | Dietary Supplement: placeboConsume 500 mL placebo/d (250 mL placebo twice daily) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject inclusion criteria were age 18-25 y,
- BMI [body weight divided by height squared (in kg/m2)] > 23,
- lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
- the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.
Key exclusion criteria (9 listed)
- overuse of alcohol,
- viral hepatitis,
- type 1 or 2 diabetes,
- gastrointestinal or connective diseases,
- chronic pancreatitis,
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 |
|---|---|---|
| Chinese bayberry juiceConsume 500 mL CBJ/d (250 mL CBJ twice daily) | Dietary supplement | Chinese bayberry juice |
| placebo | Dietary supplement | Placebo |
Primary outcome
Plasma lipids profile
Time frame: Four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Derived from this study: PubMed 24377455Guo H, Zhong R, Liu Y, Jiang X, Tang X, Li Z, Xia M, Ling W. Effects of bayberry juice on inflammatory and apoptotic markers in young adults with features of non-alcoholic fatty liver disease. Nutrition. 2014 Feb;30(2):198-203. doi: 10.1016/j.nut.2013.07.023.
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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.
Wenyi Zhong, MD study director
Shaoguan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese bayberry juice in people with Nonalcoholic Fatty Liver Disease, run by Shaoguan University at 1 site in China.
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 9 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: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lipids profile (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01707914, which also lists 1 linked publication.
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 4 Dec 2012.