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

NCT06972524 | Not Yet Recruiting

• 1 other identifier: MN-2025-02
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pre-biabetes

Outcome Measures

Primary Outcomes (3)

• fasting blood glucose

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

  up to 8 weeks

• 2h-piAUC after standardized breakfast

  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.

  up to 8 weeks

• TIR (time in range)

  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.

  up to 8 weeks

Secondary Outcomes (7)

• HbA1c

  up to 8 weeks

• weight

  up to 8 weeks

• intestinal bacteria

  up to 8 weeks

• lipid metabolism

  up to 8 weeks

• sleep quality

  up to 8 weeks

Study Arms (2)

probiotics group

EXPERIMENTAL

a special probiotics from Mengniu Group, supplemented with milk powder

Dietary Supplement: a special probiotics from Mengniu Group, supplemented with milk powder

placebo group

PLACEBO COMPARATOR

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

Interventions

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

probiotics group

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

placebo group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huilian Zhu: lead

MeSH Terms

Interventions

Flavoring Agents; Taste

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: May 15, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-10