Effects of Milk Powder Intervention on Blood Glucose Control and Fluctuation in Middle-aged and Elderly People With Pre-diabetes
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: fortified formula milk powder group, regular milk powder group.
- Who it may be relevant to
- Registry conditions: Pre-diabetes. 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
Effects of Daily Supplementation With Milk Powder on Blood Glucose Control and Fluctuation in Middle-aged and Older Adults: A Randomized Control Trial
Overview
This study aims to conduct a 8-week intervention involving one formula milk powder for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control and fluctuations in comparison to interventions using regular milk powder.
Interventions
- Dietary supplement fortified formula milk powder group
Fortified formula milk powder is supplemented with fiber, bitter gourd powder,mulberry leaves extract, whitekidney beans extract, and probiotics, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day for a duration of 8 weeks. - Dietary supplement regular milk powder group
Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.
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: NCT06863766 · MN-2024-07