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

NCT06401161 | Enrolling By Invitation

• 1 other identifier: LonggangDPHS
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Keywords

Pu' er Tea; glucose and lipid metabolism; intestinalflora

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (8)

• Creatinine

  0week

• Creatinine

  12weeks

• Creatinine

  52weeks

• Bone densitometry

  0 week

• Bone densitometry

  52 weeks

Study Arms (2)

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.

Other: 3T Pu'er tea

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.

Other: 3T Pu'er tea

Interventions

3T Pu'er tea OTHER

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

Also known as: Traditional Pu'er tea

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 2 diabetes and insulin injections or oral hypoglycemic drugs and other special types of diabetes.
• For women during pregnancy or lactation or with allergies;
• 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);
• Patients with severe cardiovascular diseases, cerebrovascular diseases, liver, kidney, and hematopoietic diseases;
• Combined with other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome;
• Take probiotics, prebiotics, antioxidants and fish oil nutrient supplements within 3 months;
• Current smokers and regular drinking (excluding social drinkers only);
• Yogurt intake within 1 week before the first visit and antibiotics within 3 months;
• Drink strong tea regularly;
• Participate in other clinical trials within 3 months;
• Unable not cooperate with the investigator for other reasons.
• Unfit for the researcherr.

Sponsors & Collaborators

• Longgang District People's Hospital of Shenzhen: lead

Study Sites (1)

Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, 518172, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: May 6, 2024
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)