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NCT Number: NCT06972524

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

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

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Key information

Conditions

Pre-biabetes

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a special probiotics from Mengniu Group, supplemented with milk powder

Dietary Supplement

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

regular milk powder does not contain any additional supplementation, and the color, flavor, shape, taste, and weight are same with the probiotic milk powder

Dietary Supplement

Sorbitol、Xylitol 、Food Flavoring 、Mono- and Diglycerides of Fatty Acids 、Silicon Dioxide、Maltodextrin

Primary outcomes

  1. fasting blood glucose

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.

  2. 2h-piAUC after standardized breakfast

    Time frame: up to 8 weeks

    the positive increment of area under curve in 2 hours after standardized breakfast standardized breakfast, measured by continuous glucose monitoring at baseline, and 8 weeks.

  3. TIR (time in range)

    Time frame: up to 8 weeks

    TIR refers to the time when blood glucose is controlled within a reasonable ( target ) range (3.9~10.0 mmol/L), measured by continuous glucose monitoring at baseline and 8 weeks.

Secondary outcomes

  1. HbA1c

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.

  2. weight

    Time frame: up to 8 weeks

    t baseline, and 8 weeks, investigators will examine weight.

  3. intestinal bacteria

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria.

  4. lipid metabolism

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride.

  5. sleep quality

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use the Pittsburgh sleep quality index scale to examine sleep quality.

  6. blood pressure

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor

  7. Continuous Glucose Monitoring (CGM) Data

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants

Sponsors and collaborators

Lead sponsor

Huilian Zhu

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.