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The effect of L.casei LC2W on the improvement of blood glucose in the high risk population of metabolic syndrome diabetes mellitus: a randomized controlled trial

The effect of L.casei LC2W on the improvement of blood glucose in the high risk population of metabolic syndrome diabetes mellitus: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031833
Enrollment
Unknown
Registered
2020-04-11
Start date
2020-04-09
Completion date
Unknown
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

experimental group:Intake Probiotic A which contains L.casei LC2W
control group:Intake Probiotic B

Sponsors

Bright Dairy Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female subjects, 45 to 65 years of age; 2. High Risk Diabete Adults Blood glucose is 6.1 to 6.9; 3. Subject who has not taken drug treatment yet; 4. Subject who can understand the objectives and requirements of the study including the potential risk and advser effect; 5. Subject who voluntarily agrees to join this study and to follow the study design 6. Agreed to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subject who has beem medical diagnosed as diabete and has already taken drug treatment. 2. Subject who is in the treatment of gastrointestinal disease. 3. Subject who is having diarrhea currently. 4. Subject who is taking analgesic medicines such as Aspirin or Acetaminophen. 5. Subject who took laxatives or other materials which can promote digestion 2 weeks before the initiation of the study. 6. Subject who takes probiotics powder treatment for long period. 7. Subject who takes medicine which has control or prevention effect on Upper Respiratory Tract Infection (URTI) symptoms for long period, such as antihistamine drugs, antitussive drugs, high-dose Vitamin C, etc. 8. Subject who took medicines which can interfere the immunity in the past 3 months, such as antibiotics. 9. Subject who has been vaccinated with Upper Respiratory Tract Infection (URTI) vaccine in the past 6 months or other vaccines with 15 days. 10. Subject who has alcohol or drug addiction history. 11. Emale subject who is pregnant or in lactation or is going to get pregnant in the study intervention period. 12. Subject who has participated in other clinical studies in the past 3 months. 13. If the enrolled subject's blood glucose increases constantly so that enters into the medical treatment phase, the subject shall withdraw from the study voluntarily. 14. Subject who has bad compliance evaluated by PI.

Design outcomes

Primary

MeasureTime frame
Fasting Blood Glucose;OGTT;Blood Insulin;HbA1c;

Secondary

MeasureTime frame
HDL-C;LDL-C;TC;TG;hsCRP;IL 6;IL 8;TNF a;MDA;SOD;

Countries

China

Contacts

Public ContactDingfu Zhong

Department of Gastroenterology, Jinhua People's Hospital

1772143482@qq.com+86 15905892382

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026