Effects of Daily Supplementation With Milk Powder on Blood Glucose Control and Fluctuation in Middle-aged and Older Adults: A Randomized Control Trial
| Registry | NCT06863766 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, basic science |
| Enrollment | 110 (Estimated) |
| Sponsor | Huilian Zhu (Other) |
| Conditions | Pre-diabetes |
| Interventions | fortified formula milk powder group, regular milk powder group (Dietary supplement) |
| Dates | start 2025-04-10 (estimated), primary completion 2025-12-20 (estimated), completion 2026-03-30 (estimated), first posted 2025-03-07, last updated 2025-04-03 |
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All trials for Pre-diabetes All trials of fortified formula milk powder group All trials of regular milk powder group
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| fortified formula milk powder group | Experimental | 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. |
| regular milk powder group | Placebo comparator | 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. |
Sex: All, ages: 40 Years to 75 Years, 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.