An interventional study of probiotics and plant extracts supplementation and The placebo consisted of microcrystalline cellulose in Pre-biabetes, sponsored by Huilian Zhu. Completed at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Huilian Zhu · Not applicable, Interventional, and Basic science
This study aimed to investigate the effects of probiotics and plant extracts supplementation on glucose control in adults with prediabetes.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's enrollment of 110 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State 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.
The criteria were revised on the registry on Nov 9, 2026. See what changed
Participants were eligible for inclusion if they were aged 40-75 years and had impaired fasting glucose (5.6 mmol/L ≤ FBG \< 6.9 mmol/L) or an level of 5.7-6.4%.
Key exclusion criteria were: 1) diagnosed diabetes or use of glucose-lowering medications; 2) oral antibiotic use within the preceding 2 weeks or inability or unwillingness to discontinue fiber, prebiotic, probiotic, or synbiotic supplements; 3) gastrointestinal disorders affecting digestion or absorption, or severe endocrine, cardiovascular, cerebrovascular, malignant, or other metabolic diseases; 4) pregnancy, breastfeeding, or planned pregnancy within the following 3 months; 5) weight change of >5% within the preceding 3 months or planned weight loss or dietary modification; 6) alcohol consumption >40 g/day; 7) cognitive impairment, communication difficulties, or other conditions preventing trial completion; and 8) participation in another clinical trial within the preceding 3 months or during the study.
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.
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.
The probiotics and plant extract supplementation was provided as a powder in individual sachets, each containing 1.5 g. Each sachet contained 5 × 10¹⁰ colony forming units of two probiotic strains, including Lacticaseibacillus paracasei LC-19 and Bifidobacterium animalis subsp. lactis MN-Gup, and mixed plant extracts, consisting of white kidney bean extract, mulberry leaf extract, and bitter melon extract.
Dietary Supplement: probiotics and plant extracts supplementation
The placebo consisted of microcrystalline cellulose without probiotic strains or plant extracts.
Dietary Supplement: The placebo consisted of microcrystalline cellulose
The probiotics and plant extracts supplementation was provided as a powder in individual sachets, each containing 1.5 g. Each sachet contained 5 × 10¹⁰ colony forming units of two probiotic strains, including Lacticaseibacillus paracasei LC-19 and Bifidobacterium animalis subsp. lactis MN-Gup, and mixed plant extracts, consisting of white kidney bean extract, mulberry leaf extract, and bitter melon extract.
The placebo consisted of microcrystalline cellulose and was matched to the active intervention in appearance, taste, and dosage. Participants received two sachets daily for 8 weeks, following the same administration schedule as the intervention group.
fasting blood glucose
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.
Time frame: Baseline to Week 8
2h-piAUC after standardized OGTT
the positive increment of area under curve in 2 hours after OGTT, measured by continuous glucose monitoring at baseline, and 8 weeks.
Time frame: Baseline to Week 8
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: Baseline to Week 8
HbA1c
At baseline, and 8 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.
Time frame: Baseline to Week 8
weight
at baseline, and 8 weeks, investigators will examine weight.
Time frame: Baseline to Week 8
intestinal bacteria
At baseline, and 8 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria.
Time frame: Baseline to Week 8
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: Baseline to Week 8
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: Baseline to Week 8
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: Baseline to Week 8
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Huilian Zhu