Gut bacteria and herbal compound show promise for prediabetes in obesity
NCT ID NCT05720299
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a gut bacterium called Akkermansia muciniphila and a natural compound called berberine can help manage prediabetes in obese adults. 110 overweight or obese people with prediabetes were given either the bacterium, berberine, or a placebo for 12 weeks. The goal was to see changes in blood sugar, weight, and other health markers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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110 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-65 2. Overweight/obesity (24.0≤BMI≤40.0 kg/m\^2) 3. Fasting blood glucose ≥6.1 and \<7.0 mmol/L, or 2-hour postprandial blood glucose ≥7.8 and \<11.1 mmol/L, or glycosylated hemoglobin ≥5.7% and \<6.5% 4. Fertile subjects (including male and female subjects) agreed to take effective contraceptive measures that the investigator accepted during and within 3 months after the trial (e.g. intrauterine device or a condom); the fertile female subjects with serum human chorionic gonadotropin test negative results within 7 days before the investigational product administration; Infertile female must be surgically infertile or at least 1 year after menopause. 5. Subjects should understand the nature, significance, potential benefits, inconvenience and risks of the study before the trial begins, fully understand and voluntarily sign the informed consent. Exclusion Criteria: 1. Subjects who diagnosed with diabetes mellitus, medical obesity (excluding those who have been off medication for more than 1 year), or other secondary diabetes mellitus (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly); 2. Subjects who has undergone bariatric surgery; 3. Subjects who has acute or chronic progressive or unstable disease, liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases; 3.Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months; 4.Patients with hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency; 5.History of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months; 6.Excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female) 7.Pregnant or lactating subjects 8.Subjects that the investigator considers need to excluded due to other causes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Seventh Affiliated Hospital of Southern Medical University
Foshan, Guangdong, 514500, China
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Other studies related to the condition(s) this trial covers.
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