Not Yet RecruitingNot Applicable

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

110 participantsStarted 2025-04-10

Plain-language 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.

Who can participate

Age range40 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

fasting blood glucose

Timeframe: up to 8 weeks

2h-piAUC after standardized breakfast

Timeframe: up to 8 weeks

TIR (time in range)

Timeframe: up to 8 weeks

Trial details

NCT IDNCT06863766

SponsorHuilian Zhu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-20

View on ClinicalTrials.gov More Pre-diabetes trials

Who can participate

Age range40 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.