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Enrolling by invitationNCT06401161Updated May 6, 2024

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

An interventional study of 3T Pu'er tea in Overweight and Obesity, sponsored by Longgang District People's Hospital of Shenzhen. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by Longgang District People's Hospital of Shenzhen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight
  • Obesity

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Keywords

  • Pu' er Tea
  • glucose and lipid metabolism
  • intestinalflora
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's planned enrollment of 94 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

This is the only study on the registry with Longgang District People's Hospital of Shenzhen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
94 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Other3T Pu'er tea

    Two types of Pu-erh tea with different levels of theabrownin content.

    Also known as: Traditional Pu'er tea

06

What researchers measure

Primary outcomes

  1. Blood lipids

    Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.

    Time frame: 0week

  2. Blood lipids

    Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.

    Time frame: 6weeks

  3. Blood lipids

    Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.

    Time frame: 12weeks

  4. Blood lipids

    Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.

    Time frame: 52weeks

  5. 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.

    Time frame: 0week

  6. 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.

    Time frame: 6weeks

  7. 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.

    Time frame: 12weeks

  8. 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.

    Time frame: 52weeks

  9. Hepatic fat fraction indicators

    Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.

    Time frame: 0week

  10. Hepatic fat fraction indicators

    Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.

    Time frame: 12weeks

  11. Hepatic fat fraction indicators

    Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.

    Time frame: 52weeks

  12. 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.

    Time frame: 0week

  13. 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.

    Time frame: 12weeks

  14. 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.

    Time frame: 52weeks

Secondary outcomes

  1. Creatinine

    Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Creatinine: Female 44-97umol/L, Male 53-106umol/L.

    Time frame: 0week

  2. Creatinine

    Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Creatinine: Female 44-97umol/L, Male 53-106umol/L.

    Time frame: 12weeks

  3. Creatinine

    Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Creatinine: Female 44-97umol/L, Male 53-106umol/L.

    Time frame: 52weeks

  4. 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.

    Time frame: 0 week

  5. 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.

    Time frame: 52 weeks

  6. Alanine aminotransferase

    Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.

    Time frame: 0week

  7. Alanine aminotransferase

    Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.

    Time frame: 12weeks

  8. Alanine aminotransferase

    Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.

    Time frame: 52weeks

07

Study locations

1 site
  • Longgang District People's Hospital of Shenzhen
    Shenzhen, Guangdong 518172, China
08

References and documents

Individual participant data

Plan to share: No — Study Protocol, Clinical Study Report are to be shared with other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06401161
Lead sponsor
Longgang District People's Hospital of Shenzhen
Responsible party
Chen Yuhua (Chief physician, Longgang District People's Hospital of Shenzhen) — Principal investigator
First posted
May 6, 2024
Start date
Nov 1, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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