Clinical trial NCT06401161: Study on the Effect of 3T Pu'er Tea in Regulating Glucose and Lipid Metabolism
Official title: Study on the Effect of 3T Pu'er Tea in Regulating Glucose and Lipid Metabolism
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overweight
Obesity
Keywords: Pu' er Tea
glucose and lipid metabolism
intestinalflora
Lead sponsor: Longgang District People's Hospital of Shenzhen
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Blood lipids
timeFrame: 0week
measure: Blood lipids
timeFrame: 6weeks
measure: Blood lipids
timeFrame: 12weeks
measure: Blood lipids
timeFrame: 52weeks
measure: Blood glucose
timeFrame: 0week
measure: Blood glucose
timeFrame: 6weeks
measure: Blood glucose
timeFrame: 12weeks
measure: Blood glucose
timeFrame: 52weeks
measure: Hepatic fat fraction indicators
timeFrame: 0week
measure: Hepatic fat fraction indicators
timeFrame: 12weeks
measure: Hepatic fat fraction indicators
timeFrame: 52weeks
measure: Intestinal flora detection
timeFrame: 0week
measure: Intestinal flora detection
timeFrame: 12weeks
measure: Intestinal flora detection
timeFrame: 52weeks
Secondary outcomes:
measure: Creatinine
timeFrame: 0week
measure: Creatinine
timeFrame: 12weeks
measure: Creatinine
timeFrame: 52weeks
measure: Bone densitometry
timeFrame: 0 week
measure: Bone densitometry
timeFrame: 52 weeks
measure: Alanine aminotransferase
timeFrame: 0week
measure: Alanine aminotransferase
timeFrame: 12weeks
measure: Alanine aminotransferase
timeFrame: 52weeks
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Longgang District People's Hospital of Shenzhen
state: Guangdong
Study officials:
References: