An interventional study of fortified formula milk powder group and regular milk powder group in Pre-diabetes, sponsored by Huilian Zhu. Not yet recruiting. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Huilian Zhu · Not applicable, Interventional, and Basic science
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.
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 110 is above the median of 56 across 661 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Huilian Zhu is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: fortified formula 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.
Dietary Supplement: regular 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 does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder.
fasting blood glucose
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.
Time frame: 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.
Time frame: 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.
Time frame: up to 8 weeks
HbA1c
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.
Time frame: up to 8 weeks
weight
At baseline, and 8 weeks, investigators will examine weight.
Time frame: up to 8 weeks
intestinal bacteria
At baseline, and 8 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria.
Time frame: 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.
Time frame: up to 8 weeks
sleep quality
At baseline, and 8 weeks, investigators will use the Pittsburgh sleep quality index scale to examine sleep quality.
Time frame: 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
Time frame: 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
Time frame: up to 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for Dec 2025, 8 months later.
Of 254 non-industry interventional studies with no phase under Glucose Intolerance, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 8 months is below that.
Counting every sponsor, half of 286 studies reached it within 26 months; a quarter within 10 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Huilian Zhu