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

NCT ID: NCT06401161

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

3T Pu'er tea

Intervention Type: OTHER

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

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.

Group Type: PLACEBO_COMPARATOR

3T Pu'er tea

Intervention Type: OTHER

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

Interventions

3T Pu'er tea

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

Intervention Type: OTHER

Other Intervention Names

Traditional Pu'er tea

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Longgang District People's Hospital of Shenzhen

OTHER

Sponsor Role: lead

Responsible Party

Chen Yuhua

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

LonggangDPHS

Identifier Type: -

Identifier Source: org_study_id