Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06863766

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fortified formula milk powder group

Dietary Supplement

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

Dietary Supplement

Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. HbA1c

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.

  2. weight

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will examine weight.

  3. intestinal bacteria

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria.

  4. lipid metabolism

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride.

  5. sleep quality

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will use the Pittsburgh sleep quality index scale to examine sleep quality.

  6. blood pressure

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor

  7. Continuous Glucose Monitoring (CGM) Data

    Time frame: up to 8 weeks

    At baseline, and 8 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants

Sponsors and collaborators

Lead sponsor

Huilian Zhu

Other

Registry information

Official study title

Effects of Daily Supplementation With Milk Powder on Blood Glucose Control and Fluctuation in Middle-aged and Older Adults: A Randomized Control Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.