Limonene on Regulating Metabolism-related Fatty Liver Disease (MAFLD) and Analysis of TCM Constitution

NCT04853082 | Completed Early Phase 1

• 2 other identifiers: DL-MAFLD-TCMSHDC2020CR4095
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Fatty Liver

Keywords

Metabolic associated fatty liver disease (MAFLD); Limonene; Efficacy; Safety

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at baseline, four, twelve weeks after administration

Secondary Outcomes (15)

• Difference of waist circumference

  at baseline, four, twelve weeks after administration

• Difference of aspartate transaminase (AST) index

  at baseline, four, twelve weeks after administration

• Difference of glutamic transpeptidase (GGT) index

  at baseline, four, twelve weeks after administration

• Difference of alanine transaminase (ALT) index

  at baseline, four, twelve weeks after administration

• Difference of total cholesterol (TC) index

  at baseline, twelve weeks after administration

Other Outcomes (5)

• Difference of CRP related to the mechanism of action

  at baseline, twelve weeks after administration

• Difference of IL6 related to the mechanism of action

  at baseline, twelve weeks after administration

• Difference of TNF-a related to the mechanism of action

  at baseline, twelve weeks after administration

Study Arms (2)

Limonene capsules(marketed product in China)

ACTIVE COMPARATOR

Limonene capsules(marketed product in China) donate by pharmaceutical company

Drug: Limonene capsule

Limonene capsules(Placebo)

PLACEBO COMPARATOR

Same smell, color and shape as limonene capsules(marketed product in China), without limonene in capsules

Drug: Limonene capsules(Placebo)

Interventions

Limonene capsule DRUG

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.

Also known as: DAN LENING capsule

Limonene capsules(marketed product in China)

Limonene capsules(Placebo) DRUG

Limonene capsules(Placebo)

Limonene capsules(Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Hongsheng Tan: lead
• Shanghai Shen Kang Hospital Development Center: collaborator
• Longhua Hospital: collaborator
• Hongqiao International Institute of Medicine, Shanghai Tongren Hospital and Faculty of Public Health, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Longhua Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 32278004 RESULT

MeSH Terms

Conditions

Fatty Liver

Interventions

Limonene

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Monoterpenes; Terpenes

Study Officials

• Biyun Qian, Doctor

  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

  PRINCIPAL INVESTIGATOR

• Xiaoyun Chen, Doctor

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

• Hongsheng Tan, Doctor

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Exploratory Clinical Trial；Randomized Controlled Trial

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 21, 2021
• Study Start: February 22, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

CN (1)