Multi Center Clinical Study on the Lipid-lowering Efficacy and Safety of Menggongzi Tibetan Tea Special Drink

September 23, 2024 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
About 179 million people die from cardiovascular disease each year, accounting for approximately 31% of global deaths. It is expected that this number will exceed 236 million by 2030, and the economic burden caused by this disease is increasing year by year.At present, the number of people suffering from cardiovascular diseases in China is as high as 330 million, and the mortality rate accounts for more than 40% of the total deaths caused by diseases, and is in a continuous upward trend.Long term dyslipidemia will increase the incidence rate and mortality of atherosclerotic diseases.Tibetan tea contains catechins, caffeine, amino acids, vitamins, and various mineral components, which have significant effects in reducing cholesterol, improving carbohydrate metabolism, lowering blood sugar, losing weight, softening human blood vessels, and other aspects.At present, there are no research reports on the lipid-lowering effect of Mongolian Gongzi Tibetan Tea Special Drink, and most studies on the lipid-lowering effect of Tibetan Tea are animal experiments or clinical observational studies. Therefore, this study intends to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Mongolian Gongzi Tibetan Tea Special Drink in patients with hyperlipidemia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Every year, approximately 179 million people die from cardiovascular diseases, accounting for about 31% of global deaths. This number is expected to exceed 236 million by 2030, and the economic burden of these diseases is increasing year by year. Currently, in China, there are up to 330 million people suffering from cardiovascular diseases, with the mortality rate exceeding 40% of disease-related deaths and continuing to rise. Chronic dyslipidemia increases the incidence and mortality of atherosclerotic cardiovascular disease (ASCVD). Hyperlipidemia refers to elevated levels of one or more lipids in the plasma due to abnormal lipid metabolism or transport, leading to deposition in the vascular endothelium and causing damage to the body. This condition manifests as hypercholesterolemia, hypertriglyceridemia, or low high-density lipoprotein cholesterol. Additionally, this disease is closely related to the onset of stroke, diabetes, hypertension, fatty liver, and other conditions. In recent years, the incidence of hyperlipidemia has significantly increased due to changes in lifestyle, especially dietary habits. The atherosclerotic cardiovascular diseases caused by hyperlipidemia are often characterized by high incidence, severe harm, and rapid disease progression. Hyperlipidemia is becoming an invisible killer of human health.

Statins are the most recommended medication for ASCVD due to their significant effect in lowering low-density lipoprotein cholesterol, with strong evidence supporting their use. However, the side effects of statins have not been fully resolved. Among patients receiving statin treatment, 10%-29% may experience statin-related muscle symptoms, such as cramps, myalgia, weakness, immune-mediated necrotizing myopathy, and more rarely, rhabdomyolysis. Medium-intensity statins may increase the risk of type 2 diabetes by approximately 11%, while high-intensity statins might increase the risk by 20% or more. Early clinical trials of statins showed that up to 2% of patients experienced elevated transaminases, and the impact on renal function remains controversial. Additionally, statin-related adverse events include cataracts, gastrointestinal issues, effects on the genitourinary system, gynecomastia, and reproductive issues. Balancing the benefits and risks of statin therapy is a crucial challenge for all cardiovascular doctors.

Tea is one of the world's three major non-alcoholic beverages and has been used both as a food and medicine for over 5000 years. Yaan Tibetan tea is a local specialty black tea, named after its primary production in Yaan, Sichuan Province, and historically popular in Tibetan areas such as Tibet and Qinghai. Tibetan tea contains catechins, caffeine, amino acids, vitamins, and various minerals, particularly rich in tea pigments, tea polysaccharides, and tea saponins. Besides the general benefits of tea such as anti-cancer, anti-aging, antioxidant, anti-bacterial, and anti-radiation effects, it has significant effects on lipid reduction, improving carbohydrate metabolism, lowering blood sugar, weight loss, and softening blood vessels. Meng Gongzi Tibetan Tea Special Drink is made from Tibetan tea, using modern green separation and purification technology to extract and concentrate key functional components like tea polysaccharides and tea pigments. It adds sorbitol, which is indigestible and harmless to the human body, to enhance palatability and is produced using instant sterilization and hot filling technology without preservatives, strictly according to GB/T21733 standards, resulting in a convenient drink with high tea pigment and polysaccharide content.

Currently, there is no research report on Meng Gongzi Tibetan Tea Special Drink, and studies on the lipid-lowering effects of Tibetan tea are mostly animal experiments or observational studies. Therefore, this study aims to use a randomized controlled trial to explore the lipid-lowering efficacy and safety of Meng Gongzi Tibetan Tea Special Drink for patients with hyperlipidemia.

Study Type

Interventional

Enrollment (Estimated)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Meets the diagnostic criteria for hyperlipidemia: total cholesterol (TC) ≥ 6.20mmol/L, triglycerides (TG) ≥ 2.30 mmol/L. If one of the above blood lipid indicators is abnormal, it can be included in this study;
  2. Age ≥ 18 years old, gender not limited;
  3. The patient is willing to follow the research protocol and sign an informed consent form.

Exclusion Criteria:

  1. Atherosclerotic cardiovascular disease (ASCVD) patients;
  2. Diabetes patients;
  3. Severe hypercholesterolemia (TC>8 mmol/L or LDL-C ≥ 4.9 mmol/L) or severe hypertriglyceridemia (TG ≥ 5.6 mmol/L);
  4. Secondary hyperlipidemia;
  5. Individuals with a family history of primary hypercholesterolemia;
  6. Active liver disease or unexplained persistent elevation of serum transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2-fold upper limit of normal (ULN));
  7. The estimated glomerular filtration rate (eGFR) is less than 30 mL/min/1.73m2;
  8. Creatine kinase (CK)>3 times ULN;
  9. Individuals who have used any lipid-lowering drugs within the past month; 10）Individuals allergic to Tibetan tea and atorvastatin calcium;

11) Individuals with combined mental illnesses or malignant tumors; 12) Pregnant and lactating women; 13) Researchers consider patients who are not suitable for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Menggongzi Tibetan Tea Special Drink (50ml/time, taken after breakfast and lunch)+Low fat diet
Other: Menggongzi Tibetan Tea Special Drink
Menggongzi Tibetan Tea Special Drink (50ml/time, taken after breakfast and lunch)+Low fat diet
Active Comparator: Positive control group
Atorvastatin Calcium Tablets (20mg, qn)+Low fat diet
Drug: Atorvastatin Calcium 20Mg Tab
Atorvastatin Calcium Tablets (20mg, qn)+Low Fat Diet
Other: Negative control group
Low fat diet
Other: Low fat diet
Low fat diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TC
Time Frame: 4 weeks
Comparison of TC levels between Tibetan tea and a simple low-fat diet compared to baseline
4 weeks
TG
Time Frame: 4 weeks
Comparison of TG levels between Tibetan tea and atorvastatin compared to baseline
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

August 8, 2025

Study Completion (Estimated)

August 8, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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