Status:
NOT_YET_RECRUITING
Effects of Milk Probiotics Intervention on Blood Glucose Control Middle-aged and Elderly People With Pre-diabetes
Lead Sponsor:
Huilian Zhu
Conditions:
Pre-biabetes
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
This study aims to conduct a 8-week probiotics intervention involving for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control in comparison to placebo
Eligibility Criteria
Inclusion
- Age between 40 and 75 years, regardless of gender.
- 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).
- Resided in Guangzhou for the past six months and no plans to relocate or travel outside the city in the next month.
- Signed informed consent form and voluntarily agreed to participate in the project.
Exclusion
- Patients with a confirmed diagnosis of diabetes who are currently taking glucose-lowering medications (e.g., insulin, GLP-1 receptor agonists, or SGLT2 inhibitors).
- Individuals with lactose intolerance or dairy product intolerance.
- Pregnant, planning to become pregnant within the next three months, or currently breastfeeding.
- Weight change \> 5% in the past three months or plans to lose weight or change dietary habits.
- Alcohol consumption \> 40g/day.
- Individuals with communication barriers, cognitive impairments, or other conditions that may prevent them from completing the study procedures.
- 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.
- Participation in or current involvement in other clinical trials within the past three months.
- No use of antibiotic medications within the past three months.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06972524
Start Date
December 1 2025
End Date
June 30 2026
Last Update
November 25 2025
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