Study on the Effect of 3T Pu'er Tea in Regulating Glucose and Lipid Metabolism

To study the effect of Pu'er tea in overweight / obese patients with blood glucose or abnormal lipid metabolism. Compared with the effect of two Pu'er tea with different tea fuscin content in improving glucose and lipid metabolism, to investigate the mechanisms of bile acid metabolism and intestinal flora regulation.

In a prospective randomized controlled clinical study, 90 patients were divided into study group (3T Pu'er tea group, 45 patients) and control group ( traditional Pu'er tea group,45 patients). Before and after the treatment(0day, 12 weeks, 52 weeks) patients' markers of glucose and lipid metabolism were examined and compared.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: 3T Pu'er tea

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518172
      • Longgang District People's Hospital of Shenzhen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The A、B should be simultaneously met, or combined with the C、D、E.

1. 18-65 years, priority for patients over 30 years;
2. Overweight / obese patients: BMI ≥24 kg/m2.
3. Or combined with nonalcoholic fatty liver disease: determined by the hospital MRI nuclear magnetic quantification;
4. Or combined with dyslipidemia: blood total cholesterol TC≥6.4mmol/L or blood total triglyceride TG≥2.0mmol/L or blood low-density lipoprotein LDL-C≥3.1mmol/L;

5. Or with abnormal blood glucose:

   • Impaired fasting glucose, IFG: fasting blood glucose was 6.1~<7.0mmol/L,and 2 hours after 75g oral blood glucose tolerance test(OGTT) <7.8mmol / L.
   • Impaired glucose tolerance, IGT: the fasting blood glucose was <6.1mmol/L and 2 hours after 75gOGTT was 7.8~ <11.1 mmol / L;
   • IFG with IGT: patients with both IFG and IGT;
   • Patients with type 2 diabetes: random blood glucose 11.1mmol/L or fasting glucose of 7.0 mmol/L or 2 hours after OGTT.

Exclusion Criteria:

1. Type 2 diabetes and insulin injections or oral hypoglycemic drugs and other special types of diabetes.
2. For women during pregnancy or lactation or with allergies;
3. Patients treated with any hypoglycemic drugs and insulin injections; regular or planned patients taking drugs that may affect glucose and lipid metabolism (as judged by clinicians, such as diet pills, lipid-lowering drugs) and liver protection drugs (as judged by clinicians);
4. Patients with severe cardiovascular diseases, cerebrovascular diseases, liver, kidney, and hematopoietic diseases;
5. Combined with other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome;
6. Take probiotics, prebiotics, antioxidants and fish oil nutrient supplements within 3 months;
7. Current smokers and regular drinking (excluding social drinkers only);
8. Yogurt intake within 1 week before the first visit and antibiotics within 3 months;
9. Drink strong tea regularly;
10. Participate in other clinical trials within 3 months;
11. Unable not cooperate with the investigator for other reasons.
12. Unfit for the researcherr.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The recommended method for consuming 3T Pu-erh tea is as follows: according to individual preferences, once a day, 8 g/time, or twice a day, 4 g/time, using a 300 mL stew cup; Steep the tea in 200 mL of boiling water for 60-90 seconds and consume. The tea can be brewed multiple times, replacing regular water intake. Ensure that the entirety of the liquid in the cup is consumed during each session.	Other: 3T Pu'er tea; Two types of Pu-erh tea with different levels of theabrownin content.; Other Names: Traditional Pu'er tea
Placebo Comparator: Control group; The recommended method for consuming traditional Pu-erh tea is as follows: according to individual preferences, once a day, 8 g/time, or twice a day, 4 g/time, using a 300 mL stew cup; Steep the tea in 200 mL of boiling water for 60-90 seconds and consume. The tea can be brewed multiple times, replacing regular water intake. Ensure that the entirety of the liquid in the cup is consumed during each session.	Other: 3T Pu'er tea; Two types of Pu-erh tea with different levels of theabrownin content.; Other Names: Traditional Pu'er tea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	0week
Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	6weeks
Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	12weeks
Blood lipids	Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.	52weeks
Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range：Fasting Blood Glucose 3.9-6.1 mmol/L.	0week
Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range：Fasting Blood Glucose 3.9-6.1 mmol/L.	6weeks
Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range：Fasting Blood Glucose 3.9-6.1 mmol/L.	12weeks
Blood glucose	Blood glucose were detected by the Roche COBAS C702 biochemical analyzer.Normal reference range：Fasting Blood Glucose 3.9-6.1 mmol/L.	52weeks
Hepatic fat fraction indicators	Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.	0week
Hepatic fat fraction indicators	Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.	12weeks
Hepatic fat fraction indicators	Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.	52weeks
Intestinal flora detection	Polymerase Chain Reaction amplification was carried out in the v1-v9 variable region of the 16S rRN gene using universal primer (27F-1492R), and sequencing was conducted in the Illumina novaseq platform. The 16S rRNA amplicon sequence was processed using QIIME2. VSEARCH software was adopted to splice, filter, and remove chimeras from the original sequence to obtain the effective sequences. Clustering was performed according to the 99% similarity of the sequences to obtain the operational taxonomic units (OTU). Based on the Silva NR99 132 database, the representative sequences were analyzed and annotated. The OTU list was generated. The abundance and classification of all OTUs in the samples were recorded.	0week
Intestinal flora detection	Polymerase Chain Reaction amplification was carried out in the v1-v9 variable region of the 16S rRN gene using universal primer (27F-1492R), and sequencing was conducted in the Illumina novaseq platform. The 16S rRNA amplicon sequence was processed using QIIME2. VSEARCH software was adopted to splice, filter, and remove chimeras from the original sequence to obtain the effective sequences. Clustering was performed according to the 99% similarity of the sequences to obtain the operational taxonomic units (OTU). Based on the Silva NR99 132 database, the representative sequences were analyzed and annotated. The OTU list was generated. The abundance and classification of all OTUs in the samples were recorded.	12weeks
Intestinal flora detection	Polymerase Chain Reaction amplification was carried out in the v1-v9 variable region of the 16S rRN gene using universal primer (27F-1492R), and sequencing was conducted in the Illumina novaseq platform. The 16S rRNA amplicon sequence was processed using QIIME2. VSEARCH software was adopted to splice, filter, and remove chimeras from the original sequence to obtain the effective sequences. Clustering was performed according to the 99% similarity of the sequences to obtain the operational taxonomic units (OTU). Based on the Silva NR99 132 database, the representative sequences were analyzed and annotated. The OTU list was generated. The abundance and classification of all OTUs in the samples were recorded.	52weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Creatinine: Female 44-97umol/L, Male 53-106umol/L.	0week
Creatinine	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Creatinine: Female 44-97umol/L, Male 53-106umol/L.	12weeks
Creatinine	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Creatinine: Female 44-97umol/L, Male 53-106umol/L.	52weeks
Bone densitometry	The bone mineral density of the axial skeleton (L1-4 vertebrae, left femoral neck, total hip) of the subjects was measured in g/cm2 using a dual-energy X-ray absorptiometry (coefficient of variation <1%) from Hologic, USA.	0 week
Bone densitometry	The bone mineral density of the axial skeleton (L1-4 vertebrae, left femoral neck, total hip) of the subjects was measured in g/cm2 using a dual-energy X-ray absorptiometry (coefficient of variation <1%) from Hologic, USA.	52 weeks
Alanine aminotransferase	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.	0week
Alanine aminotransferase	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.	12weeks
Alanine aminotransferase	Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.	52weeks

Collaborators and Investigators

• Sponsor: Longgang District People's Hospital of Shenzhen

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: May 2, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pu' er Tea; glucose and lipid metabolism; intestinalflora
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: LonggangDPHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study Protocol, Clinical Study Report are to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No