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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
Two types of Pu-erh tea with different levels of theabrownin content.
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Blood lipids
Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.
Time frame: 0week
Blood lipids
Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.
Time frame: 6weeks
Blood lipids
Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.
Time frame: 12weeks
Blood lipids
Blood lipids were detected by the Roche COBAS C702 biochemical analyzer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 52weeks
Hepatic fat fraction indicators
Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.
Time frame: 0week
Hepatic fat fraction indicators
Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.
Time frame: 12weeks
Hepatic fat fraction indicators
Siemens 3.0T medical MRI equipment was applied for MAFLD diagnosis and fat quantitative assessment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 52weeks
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
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
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
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
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
Alanine aminotransferase
Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.
Time frame: 0week
Alanine aminotransferase
Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.
Time frame: 12weeks
Alanine aminotransferase
Creatinine was detected by the Roche COBAS C702 biochemical analyzer. Normal reference range：Alanine aminotransferase: 0-40U/L.
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Time frame: 52weeks