Effects of Milk Probiotics Intervention on Blood Glucose Control Middle-aged and Elderly People With Pre-diabetes
Launched by HUILIAN ZHU · May 13, 2025
Trial Information
Current as of July 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how milk probiotics might help control blood sugar levels in middle-aged and elderly people who are at risk of developing diabetes, known as pre-diabetes. Over eight weeks, participants will take either a probiotic drink or a placebo (a drink with no active ingredients) to see if it makes a difference in their blood glucose levels.
To join the study, you need to be between 40 and 75 years old and have slightly elevated blood sugar levels, but not full-blown diabetes. You should also have been living in Guangzhou for the last six months and not plan to travel outside the city soon. Unfortunately, if you have diabetes, lactose intolerance, are pregnant, or have certain health issues, you may not be eligible. If you take part, you can expect regular monitoring of your blood sugar and to learn more about how diet can impact your health. This study is an important step in understanding how probiotics might help people at risk for diabetes.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age between 40 and 75 years, regardless of gender.
- • 2. Impaired fasting glucose (5.6 mmol/L ≤ FPG \< 6.9 mmol/L) or glycated hemoglobin (HbA1c) between 5.7-6.4% (39-47 mmol/mol).
- • 3. Resided in Guangzhou for the past six months and no plans to relocate or travel outside the city in the next month.
- • 4. Signed informed consent form and voluntarily agreed to participate in the project.
- Exclusion Criteria:
- • 1. Patients with a confirmed diagnosis of diabetes who are currently taking glucose-lowering medications (e.g., insulin, GLP-1 receptor agonists, or SGLT2 inhibitors).
- • 2. Individuals with lactose intolerance or dairy product intolerance.
- • 3. Pregnant, planning to become pregnant within the next three months, or currently breastfeeding.
- • 4. Weight change \> 5% in the past three months or plans to lose weight or change dietary habits.
- • 5. Alcohol consumption \> 40g/day.
- • 6. Individuals with communication barriers, cognitive impairments, or other conditions that may prevent them from completing the study procedures.
- • 7. Severe diseases that may affect participation in the study, including but not limited to endocrine disorders, severe cardiovascular or cerebrovascular diseases, cancer, metabolic diseases, etc.
- • 8. Participation in or current involvement in other clinical trials within the past three months.
- • 9. No use of antibiotic medications within the past three months.
About Huilian Zhu
Huilian Zhu is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on high-quality, patient-centered studies, Huilian Zhu collaborates with various stakeholders, including healthcare professionals, regulatory bodies, and research institutions, to ensure the successful design and execution of clinical trials. Their expertise spans multiple therapeutic areas, emphasizing ethical practices, rigorous methodologies, and compliance with regulatory requirements. By fostering a culture of collaboration and transparency, Huilian Zhu aims to contribute significantly to the development of effective therapies that improve patient outcomes and enhance public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported