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NCT06863766 | NOT YET RECRUITING | Pre-diabetes

Effects of Milk Powder Intervention on Blood Glucose Control and Fluctuation in Middle-aged and Elderly People With Pre-diabetes
Sponsor:

Hui Z Tiger

Information provided by (Responsible Party):

Hui Z Tiger

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.

Condition or disease

Pre-diabetes

Intervention/treatment

fortified formula milk powder group

regular milk powder group

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : TRIPLE
Primary Purpose : BASIC_SCIENCE
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
Actual Study Start Date : 2025-04-10
Estimated Primary Completion Date : 2025-12-20
Estimated Study Completion Date : 2026-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
Effects of Milk Powder Intervention on Blood Glucose Control and Fluctuation in Middle-aged and Elderly People With Pre-diabetes

Location Details

NCT06863766

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How to Participate

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Locations

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