Fatty LiverEarly Phase 1DL-MAFLD-TCMNCT04853082
Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
A Early Phase 1 study testing Limonene capsule in people with Fatty Liver, run by Hongsheng Tan at 1 site in China.
Trial summary
The prevention and treatment of metabolic-related fatty liver disease (MAFLD) involves many fields in preventive medicine and clinical medicine. So far, western medicine has not yet completed the elucidation of the mechanism of this type of disease, and there is a lack of effective therapeutic drugs.The purpose of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Limonene capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2021to 25 Oct 2021
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis and imaging diagnosis of MAFLD and BMI index greater than or equal to 23kg/m2；
- The age of the recruiter is between 18-65 years old;
- Those who can cooperate with various treatments and data measurements according to the treatment cycle, and can persist in completing the test;
- Those who accept and are willing to sign the informed consent.
Who cannot join
- Potential recruiters who meet the inclusion criteria will be excluded if they meet any of the following:
- Those who routinely take prescription drugs (except regular contraceptive drugs) or those who use auxiliary Chinese and Western drugs to treat non-alcoholic fatty liver;
- Patients suffering from viral hepatitis, autoimmune hepatitis, hepatolenticular degeneration, hypothyroidism, infection, and biliary tract diseases that lead to abnormal liver function;
- Patients who have taken the following drugs in the past 4 weeks: hypoglycemic drugs, lipid-lowering drugs (such as statins, fibrates, etc.) and drugs that may affect liver fat content (such as: silybin, ursodeoxycholic acid) , Bicyclic alcohol, phosphatidylcholine and vitamin E, glucocorticoid);
- Patients with diabetes or those who have undergone bariatric surgery;
- People who have gained or lost weight by 10 kg or more in the past two months;
Show all 12Show fewer
- People who are allergic to limonene capsules; or people who are allergic to citrus foods; people who especially like to eat a lot of citrus foods (daily dosage more than 100 grams);
- Patients with severe cardiac insufficiency and malignant tumors;
- Patients who have a history of mental illness and cannot cooperate with this project;
- Pregnant and lactating women, or women or men who are willing to become pregnant or give birth during the study;
- Participate in any other clinical trials;
- Other situations where the researcher thinks it is inappropriate to participate in this research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
The prevention and treatment of metabolic-related fatty liver disease (MAFLD) involves many fields in preventive medicine and clinical medicine. So far, western medicine has not yet completed the elucidation of the mechanism of this type of disease, and there is a lack of effective therapeutic drugs.The purpose of this study was to evaluate the effectiveness and safety of limonene capsules (marketed product in China) in the treatment of metabolic-related fatty liver disease and related lipid-lowering mechanisms.
Read the detailed description
In April 2020, in the famous journal "Journal of Hepatology" in the field of liver disease, an internationally renowned liver disease expert group jointly proposed to replace non-alcoholic fatty liver disease (NAFLD) with metabolic associated fatty liver disease (MAFLD) . The concept of non-alcoholic fatty liver disease (NAFLD) was first proposed by Ludwig in 1980. It specifically refers to the excessive deposition of liver fat without excessive drinking. It is a type of liver that is closely related to insulin resistance and genetic susceptibility. Non-alcoholic fatty liver disease (NAFLD) is China country's largest chronic liver disease and the primary cause of abnormal liver enzymes in health examinations. It can lead to liver disability and death. It is also closely related to a variety of metabolic diseases and the high incidence of colorectal tumors. Western medicine has not yet fully elucidated its mechanism, and no drugs have been officially approved for the clinical treatment of NAFLD.
The new MAFLD nomenclature highlights the central role of metabolic factors in causing liver fat deposition in this type of liver disease. Traditional Chinese medicine believes that the abnormal accumulation of fat in the liver of such fatty liver patients is a pathological product of the microscopic loss of water and valley essence. It belongs to phlegm stasis, which blocks the liver collaterals. It coincides with the core of the metabolic etiology of recent liver disease experts.
Limonene is widely found in the essential oils of traditional Chinese medicine tangerine peel, green peel and other plants. Its taste is sour, sweet and pungent.It is returned to the liver and gallbladder meridian. It has an aromatic odor effect.
A large number of animal and cell experiments in the early stage have shown that limonene can inhibit the differentiation of adipocytes (pre-adipocytes) and promote the apoptosis of mature adipocytes, which is related to the inhibition of fatty acid synthesis. Toxicity load experiments show that limonene has very low toxicity. The accumulation of lipids in the liver of mice has a regulatory effect with significantly reducing the content of liver cholesterol and triglycerides, and also has a certain effect on lipid metabolism disorders, hyperglycemia and other metabolic syndromes. It can alleviate the effects of high-fat diet and N- Efficacy of nitro-L-arginine methyl ester-induced resistance to non-alcoholic fatty liver in rats. The main indication of limonene capsules (marketed product in China) is liver and gallbladder diseases. Traditional Chinese medicine believes that liver and gallbladder are related to each other. This comprehensively shows that limonene capsules are promising to be developed as a pure Chinese medicine product for the safe and effective treatment of MAFLD.
However, there has been no clinical evaluation of the clinical efficacy of limonene in the treatment of metabolic-related fatty liver disease. As a typical aromatic Chinese medicine, the mechanism of limonene in the treatment of fatty liver urgently needs to be revealed by modern medicine and molecular biology techniques.
This study intends to use a randomized, double-blind, placebo-controlled method to evaluate the effect of limonene on improving the degree of fat infiltration in patients with metabolic-related fatty liver disease (MAFLD), and to evaluate its body mass index BMI, waist circumference, waist-to-hip ratio, subcutaneous fat thickness, fat percentage, changes in metabolic components, safety,etc. The study also intends to use metabonomics, genomics, and molecular biology techniques to study the clinical relationship between metabolites and physiological and pathological changes in patients with liver fat infiltration, and to detect changes in key proteins and lipid components after drug intervention, which is to reveal mechanism on treatment of metabolic-related fatty liver disease by limonene. It is aimed to study the difference in the efficacy of limonene for people with different constitutions of traditional Chinese medicine (TCM) combined with the analysis of the constitution of TCM, and to clarify the modern scientific attributes of TCM therapy. Finally the study will develop a safe and efficient drug treatment technology to control liver fat infiltration , and to promote the development of clinical disciplines in the treatment of metabolic-related fatty liver disease.
- Conditions
- Fatty Liver
- Being tested
- Limonene capsule, Limonene capsules(Placebo)
- Keywords
- Metabolic associated fatty liver disease (MAFLD), Limonene, Efficacy, Safety
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limonene capsuleDrug
Also called DAN LENING capsule
All the recruiters will be given treatment under the guidance of basic diet. Basic dietary guidelines include high-quality protein and fresh green leafy vegetables. It need to controlled sugar, various sweets and high-calorie foods, frying and other foods with high oil content and foods with high cholesterol content. Limonene capsules group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo control group and limonene capsule administration group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the treatment group and the placebo control group at a ratio of 1:1. The drug was administered for 12 weeks, 3 times a day, 5 capsules each time.
Limonene capsules(Placebo)Drug
Limonene capsules(Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Limonene capsules(marketed product in China) | Active comparator | Limonene capsules(marketed product in China) donate by pharmaceutical company Receives: Drug: Limonene capsule |
| Limonene capsules(Placebo) | Placebo comparator | Same smell, color and shape as limonene capsules(marketed product in China), without limonene in capsules Receives: Drug: Limonene capsules(Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of controlled attenuation parameter (CAP) in liver fat
Changes in controlled attenuation parameter (CAP) in liver fat measured with transient elastography between the drug group and the placebo group.
Measured: at baseline and twelve weeks after administration
Difference of rate of BMI index
The percent change of BMI index between the drug group and the placebo group.
Measured: at baseline, four, twelve weeks after administration
Secondary outcomes (15)
Difference of waist circumference
The percent change of waist circumference between the drug group and the placebo group.
Measured: at baseline, four, twelve weeks after administration
Difference of aspartate transaminase (AST) index
The absolute values of changes in the levels of AST was compared between the two groups. Serum AST content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, four, twelve weeks after administration
Difference of glutamic transpeptidase (GGT) index
The absolute values of changes in the levels of GGT was compared between the two groups. Serum GGT content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, four, twelve weeks after administration
Difference of alanine transaminase (ALT) index
The absolute values of changes in the levels of ALT was compared between the two groups. Serum ALT content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, four, twelve weeks after administration
Difference of total cholesterol (TC) index
The absolute values of changes in the levels of TC was compared between the two groups before and after treatment. Serum TC content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of glycerin trilaurate (TG) index
The absolute values of changes in the levels of TG was compared between the two groups before and after treatment. Serum TG content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of low-density lipoprotein cholesterol (LDL-C) index
The absolute values of changes in the levels of LDLC was compared between the two groups before and after treatment. Serum LDL-C content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of high-density liptein cholesterol（HDL-C）index
The absolute values of changes in the levels of HDL-C was compared between the two groups before and after treatment. Serum HDL-C content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of apolipoprotein E (ApoE) index
The absolute values of changes in the levels of ApoE was compared between the two groups before and after treatment. Serum ApoE content of the patients were detected by an automatic biochemical analyzer before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of insulin index
The absolute values of changes in the levels of insulin was compared between the two groups before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of glycated hemoglobin（GHb）index
The absolute values of changes in the levels of GHb was compared between the two groups before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of blood sugar index
The absolute values of changes in the levels of blood sugar was compared between the two groups before and after treatment.
Measured: at baseline, twelve weeks after administration
Difference of the Short Form 36 physical component summary (SF-36 PCS) score
Using the Telephone Interview for the SF-36 PCS score (range, 0 [worst] to 100 [best]).
Measured: at baseline, two，four，six，eight，ten weeks, twelve and sixteen weeks after administration
Difference of the Chronic Liver Disease Questionnaire (CLDQ)
Using the Telephone Interview for the CLDQ score (range, 0 [worst] to 100 [best]).
Measured: at baseline, two，four，six，eight，ten weeks, twelve and sixteen weeks after administration
Difference of the Traditional Chinese of Medicine ( TCM ) Physique Questionnaire
Using the Telephone Interview for the TCM Physique Questionnaire score (range, 0 [worst] to 100 [best]).
Measured: at baseline, two，four，six，eight，ten weeks, twelve and sixteen weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start22 Feb 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
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 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory Clinical Trial；Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hongsheng Tan
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center, Longhua Hospital, Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor-investigator, Hongsheng Tan, Shanghai Jiao Tong University School of Medicine
- Investigators
- Biyun Qian, Doctor, Principal investigator, Shanghai Shen Kang Hospital Development Center;Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of MedicineXiaoyun Chen, Doctor, Principal investigator, Longhua HospitalHongsheng Tan, Doctor, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853082
- Sponsor's protocol ID
- DL-MAFLD-TCM
- Other IDs
- SHDC2020CR4095
- Acronym
- DL-MAFLD-TCM
- Status last verified
- Oct 2021
- First submitted
- 5 Apr 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
PubMed 32278004
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution
- ClinicalTrials.gov ID
- NCT04853082
- Acronym / sponsor ID
- DL-MAFLD-TCM / DL-MAFLD-TCM
- Conditions
- Fatty Liver
- Keywords
- Metabolic associated fatty liver disease (MAFLD), Limonene, Efficacy, Safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hongsheng TanUniversity, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center, Longhua Hospital, Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- 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.
The prevention and treatment of metabolic-related fatty liver disease (MAFLD) involves many fields in preventive medicine and clinical medicine. So far, western medicine has not yet completed the elucidation of the mechanism of this type of disease, and there is a lack of effective therapeutic drugs.The purpose of this study was to evaluate the effectiveness and safety of limonene capsules (marketed product in China) in the treatment of metabolic-related fatty liver disease and related lipid-lowering mechanisms.
Detailed description
In April 2020, in the famous journal "Journal of Hepatology" in the field of liver disease, an internationally renowned liver disease expert group jointly proposed to replace non-alcoholic fatty liver disease (NAFLD) with metabolic associated fatty liver disease (MAFLD) . The concept of non-alcoholic fatty liver disease (NAFLD) was first proposed by Ludwig in 1980. It specifically refers to the excessive deposition of liver fat without excessive drinking. It is a type of liver that is closely related to insulin resistance and genetic susceptibility. Non-alcoholic fatty liver disease (NAFLD) is China country's largest chronic liver disease and the primary cause of abnormal liver enzymes in health examinations. It can lead to liver disability and death. It is also closely related to a variety of metabolic diseases and the high incidence of colorectal tumors. Western medicine has not yet fully elucidated its mechanism, and no drugs have been officially approved for the clinical treatment of NAFLD.
The new MAFLD nomenclature highlights the central role of metabolic factors in causing liver fat deposition in this type of liver disease. Traditional Chinese medicine believes that the abnormal accumulation of fat in the liver of such fatty liver patients is a pathological product of the microscopic loss of water and valley essence. It belongs to phlegm stasis, which blocks the liver collaterals. It coincides with the core of the metabolic etiology of recent liver disease experts.
Limonene is widely found in the essential oils of traditional Chinese medicine tangerine peel, green peel and other plants. Its taste is sour, sweet and pungent.It is returned to the liver and gallbladder meridian. It has an aromatic odor effect.
A large number of animal and cell experiments in the early stage have shown that limonene can inhibit the differentiation of adipocytes (pre-adipocytes) and promote the apoptosis of mature adipocytes, which is related to the inhibition of fatty acid synthesis. Toxicity load experiments show that limonene has very low toxicity. The accumulation of lipids in the liver of mice has a regulatory effect with significantly reducing the content of liver cholesterol and triglycerides, and also has a certain effect on lipid metabolism disorders, hyperglycemia and other metabolic syndromes. It can alleviate the effects of high-fat diet and N- Efficacy of nitro-L-arginine methyl ester-induced resistance to non-alcoholic fatty liver in rats. The main indication of limonene capsules (marketed product in China) is liver and gallbladder diseases. Traditional Chinese medicine believes that liver and gallbladder are related to each other. This comprehensively shows that limonene capsules are promising to be developed as a pure Chinese medicine product for the safe and effective treatment of MAFLD.
However, there has been no clinical evaluation of the clinical efficacy of limonene in the treatment of metabolic-related fatty liver disease. As a typical aromatic Chinese medicine, the mechanism of limonene in the treatment of fatty liver urgently needs to be revealed by modern medicine and molecular biology techniques.
This study intends to use a randomized, double-blind, placebo-controlled method to evaluate the effect of limonene on improving the degree of fat infiltration in patients with metabolic-related fatty liver disease (MAFLD), and to evaluate its body mass index BMI, waist circumference, waist-to-hip ratio, subcutaneous fat thickness, fat percentage, changes in metabolic components, safety,etc. The study also intends to use metabonomics, genomics, and molecular biology techniques to study the clinical relationship between metabolites and physiological and pathological changes in patients with liver fat infiltration, and to detect changes in key proteins and lipid components after drug intervention, which is to reveal mechanism on treatment of metabolic-related fatty liver disease by limonene. It is aimed to study the difference in the efficacy of limonene for people with different constitutions of traditional Chinese medicine (TCM) combined with the analysis of the constitution of TCM, and to clarify the modern scientific attributes of TCM therapy. Finally the study will develop a safe and efficient drug treatment technology to control liver fat infiltration , and to promote the development of clinical disciplines in the treatment of metabolic-related fatty liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Exploratory Clinical Trial；Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Limonene capsules(marketed product in China) | Active comparator | Drug: Limonene capsuleLimonene capsules(marketed product in China) donate by pharmaceutical company |
| Limonene capsules(Placebo) | Placebo comparator | Drug: Limonene capsules(Placebo)Same smell, color and shape as limonene capsules(marketed product in China), without limonene in capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis and imaging diagnosis of MAFLD and BMI index greater than or equal to 23kg/m2；
- The age of the recruiter is between 18-65 years old;
- Those who can cooperate with various treatments and data measurements according to the treatment cycle, and can persist in completing the test;
- Those who accept and are willing to sign the informed consent.
Key exclusion criteria (12 listed)
- Potential recruiters who meet the inclusion criteria will be excluded if they meet any of the following:
- Those who routinely take prescription drugs (except regular contraceptive drugs) or those who use auxiliary Chinese and Western drugs to treat non-alcoholic fatty liver;
- Patients suffering from viral hepatitis, autoimmune hepatitis, hepatolenticular degeneration, hypothyroidism, infection, and biliary tract diseases that lead to abnormal liver function;
- Patients who have taken the following drugs in the past 4 weeks: hypoglycemic drugs, lipid-lowering drugs (such as statins, fibrates, etc.) and drugs that may affect liver fat content (such as: silybin, ursodeoxycholic acid) , Bicyclic alcohol, phosphatidylcholine and vitamin E, glucocorticoid);
- Patients with diabetes or those who have undergone bariatric surgery;
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 |
|---|---|---|
| Limonene capsuleAlso: DAN LENING capsuleAll the recruiters will be given treatment under the guidance of basic diet. Basic dietary guidelines include high-quality protein and fresh green leafy vegetables. It need to controlled sugar, various sweets and high-calorie foods, frying and other foods with high oil content and foods with high cholesterol content. Limonene capsules group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo control group and limonene capsule administration group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the treatment group and the placebo control group at a ratio of 1:1. The drug was administered for 12 weeks, 3 times a day, 5 capsules each time. | Drug | Limonene capsules(marketed product in China) |
| Limonene capsules(Placebo)Limonene capsules(Placebo) | Drug | Limonene capsules(Placebo) |
Primary outcome
Difference of controlled attenuation parameter (CAP) in liver fat
Time frame: at baseline and twelve weeks after administration
Changes in controlled attenuation parameter (CAP) in liver fat measured with transient elastography between the drug group and the placebo group.
Difference of rate of BMI index
Time frame: at baseline, four, twelve weeks after administration
The percent change of BMI index between the drug group and the placebo group.
15 secondary outcomes
Difference of waist circumference
Time frame: at baseline, four, twelve weeks after administration
Difference of aspartate transaminase (AST) index
Time frame: at baseline, four, twelve weeks after administration
Difference of glutamic transpeptidase (GGT) index
Time frame: at baseline, four, twelve weeks after administration
Difference of alanine transaminase (ALT) index
Time frame: at baseline, four, twelve weeks after administration
Difference of total cholesterol (TC) index
Time frame: at baseline, twelve weeks after administration
Difference of glycerin trilaurate (TG) index
Time frame: at baseline, twelve weeks after administration
Difference of low-density lipoprotein cholesterol (LDL-C) index
Time frame: at baseline, twelve weeks after administration
Difference of high-density liptein cholesterol（HDL-C）index
Time frame: at baseline, twelve weeks after administration
Difference of apolipoprotein E (ApoE) index
Time frame: at baseline, twelve weeks after administration
Difference of insulin index
Time frame: at baseline, twelve weeks after administration
Difference of glycated hemoglobin（GHb）index
Time frame: at baseline, twelve weeks after administration
Difference of blood sugar index
Time frame: at baseline, twelve weeks after administration
Difference of the Short Form 36 physical component summary (SF-36 PCS) score
Time frame: at baseline, two，four，six，eight，ten weeks, twelve and sixteen weeks after administration
Difference of the Chronic Liver Disease Questionnaire (CLDQ)
Time frame: at baseline, two，four，six，eight，ten weeks, twelve and sixteen weeks after administration
Difference of the Traditional Chinese of Medicine ( TCM ) Physique Questionnaire
Time frame: at baseline, two，four，six，eight，ten weeks, twelve and sixteen weeks after administration
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 2 Nov 2021.
- Results publication: PubMed 32278004Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
Related trials for Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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.
Biyun Qian, Doctor principal investigator
Shanghai Shen Kang Hospital Development Center;Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine
Xiaoyun Chen, Doctor principal investigator
Longhua Hospital
Hongsheng Tan, Doctor principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Limonene capsule in people with Fatty Liver, run by Hongsheng Tan 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 12 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 2 Nov 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Difference of controlled attenuation parameter (CAP) in liver fat (time frame: at baseline and twelve weeks after administration). The study lists 2 primary outcomes in all. 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 NCT04853082, 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 2 Nov 2021.