Effects of Daily Supplementation With Milk Powder on Blood Glucose Control and Fluctuation in Middle-aged and Older Adults: A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 110
- Primary Endpoint
- fasting blood glucose
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: fortified formula milk powder group (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.
Intervention: regular milk powder group (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- weight(up to 8 weeks)
- intestinal bacteria(up to 8 weeks)
- sleep quality(up to 8 weeks)
- HbA1c(up to 8 weeks)
- lipid metabolism(up to 8 weeks)
- blood pressure(up to 8 weeks)
- Continuous Glucose Monitoring (CGM) Data(up to 8 weeks)
Investigators
Huilian Zhu
Professor
Sun Yat-sen University