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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Pre-biabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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probiotics group

a special probiotics from Mengniu Group, supplemented with milk powder

Group Type EXPERIMENTAL

a special probiotics from Mengniu Group, supplemented with milk powder

Intervention Type 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

placebo 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

Group Type 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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes