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

Huilian Zhu

Status: Not yet enrolling

Conditions: Pre-biabetes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06972524

MN-2025-02

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

probiotics group

Experimental group

Description:

a special probiotics from Mengniu Group, supplemented with milk powder

Treatment:

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

placebo group

Placebo Comparator group

Description:

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

Treatment:

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