Effects of Daily Supplementation With Milk Powder on Blood Glucose Control and Fluctuation in Middle-aged and Older Adults: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- fasting blood glucose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: regular milk powder group (Dietary Supplement)
结局指标
主要结局
fasting blood glucose
时间窗: up to 8 weeks
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.
TIR (time in range)
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Huilian Zhu
Professor
Sun Yat-sen University