Pre-diabetesNCT06863766
Effects of Milk Powder Intervention on Blood Glucose Control and Fluctuation in Middle-aged and Elderly People With Pre-diabetes
A study testing fortified formula milk powder group and regular milk powder group in people with Pre-diabetes, run by Huilian Zhu.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- fortified formula milk powder group and regular milk powder group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
- Conditions
- Pre-diabetes
- Being tested
- fortified formula milk powder group, regular milk powder group
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified formula milk powder groupDietary 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 groupDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| fortified formula milk powder group | Experimental | 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. Receives: Dietary Supplement: fortified formula milk powder group |
| regular milk powder group | Placebo comparator | Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. Receives: Dietary Supplement: regular milk powder group |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.
Measured: up to 8 weeks
2h-piAUC after standardized breakfast
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.
Measured: up to 8 weeks
TIR (time in range)
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.
Measured: up to 8 weeks
Secondary outcomes (7)
HbA1c
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.
Measured: up to 8 weeks
weight
At baseline, and 8 weeks, investigators will examine weight.
Measured: up to 8 weeks
intestinal bacteria
At baseline, and 8 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria.
Measured: up to 8 weeks
lipid metabolism
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride.
Measured: up to 8 weeks
sleep quality
At baseline, and 8 weeks, investigators will use the Pittsburgh sleep quality index scale to examine sleep quality.
Measured: up to 8 weeks
blood pressure
At baseline, and 8 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor
Measured: up to 8 weeks
Continuous Glucose Monitoring (CGM) Data
At baseline, and 8 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start10 Apr 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huilian Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huilian Zhu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863766
- Sponsor's protocol ID
- MN-2024-07
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06863766
- Acronym / sponsor ID
- MN-2024-07
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Huilian ZhuUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fortified formula milk powder group | Experimental | Dietary Supplement: fortified formula milk powder groupFortified 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 groupRegular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fortified formula milk powder groupFortified 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. | Dietary supplement | fortified formula milk powder group |
| regular milk powder groupRegular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. | Dietary supplement | regular milk powder group |
Primary outcome
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.
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.
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.
7 secondary outcomes
HbA1c
Time frame: up to 8 weeks
weight
Time frame: up to 8 weeks
intestinal bacteria
Time frame: up to 8 weeks
lipid metabolism
Time frame: up to 8 weeks
sleep quality
Time frame: up to 8 weeks
blood pressure
Time frame: up to 8 weeks
Continuous Glucose Monitoring (CGM) Data
Time frame: up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fortified formula milk powder group and regular milk powder group in people with Pre-diabetes, run by Huilian Zhu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting blood glucose (time frame: up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.