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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3T Pu'er tea | Other | Two types of Pu-erh tea with different levels of theabrownin content. |
|
| 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. |
| 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. |
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Inclusion Criteria:
The A、B should be simultaneously met, or combined with the C、D、E.
18-65 years, priority for patients over 30 years;
Overweight / obese patients: BMI ≥24 kg/m2.
Or combined with nonalcoholic fatty liver disease: determined by the hospital MRI nuclear magnetic quantification;
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;
Or with abnormal blood glucose:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longgang District People's Hospital of Shenzhen | Shenzhen | Guangdong | 518172 | China |
Study Protocol, Clinical Study Report are to be shared with other researchers.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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 |
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |