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Not yet recruiting NCT06972524

Effects of Milk Probiotics Intervention on Blood Glucose Control Middle-aged and Elderly People With Pre-diabetes

No phase Interventional Pre-biabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a special probiotics from Mengniu Group, supplemented with milk powder, regular milk powder does not contain any additional supplementation, and the color, flavor, shape, taste, and weight are same with the probiotic milk powder.
Who it may be relevant to
Registry conditions: Pre-biabetes. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Improvements of Probiotics Intervention on Blood Glucose Control in Middle-aged and Older Adults: A 8 Weeks Randomized Control Trial

Overview

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

Interventions

  • Dietary supplement a special probiotics from Mengniu Group, supplemented with milk powder
    Sorbitol 、Xylitol 、Paracaseobacterium LC19 、Bifidobacterium lactis subsp. animalis MN-Gup 、Mulberry Leaf Extract 、Bitter Melon Powder 、Resistant Dextrin 、White Kidney Bean Extract 、Stachyose 、Galactooligosaccharides 、Food Flavoring、Mono- and Diglycerides of Fatty Acids 、Silicon Dioxide
  • Dietary supplement regular milk powder does not contain any additional supplementation, and the color, flavor, shape, taste, and weight are same with the probiotic milk powder
    Sorbitol、Xylitol 、Food Flavoring 、Mono- and Diglycerides of Fatty Acids 、Silicon Dioxide、Maltodextrin

Primary outcome measures

  • fasting blood glucose [Time frame: up to 8 weeks]
  • 2h-piAUC after standardized breakfast [Time frame: up to 8 weeks]
  • TIR (time in range) [Time frame: up to 8 weeks]
Secondary outcome measures (7)
  • HbA1c [Time frame: up to 8 weeks]
  • weight [Time frame: up to 8 weeks]
  • intestinal bacteria [Time frame: up to 8 weeks]
  • lipid metabolism [Time frame: up to 8 weeks]
  • sleep quality [Time frame: up to 8 weeks]
  • blood pressure [Time frame: up to 8 weeks]
  • Continuous Glucose Monitoring (CGM) Data [Time frame: up to 8 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06972524 · MN-2025-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗