About this trial
The goal of this clinical trial is to learn if Dihydroberberine (DHB) supplementation affects adults with pre-diabetes.
The main questions it aims to answer are:
Does DHB supplementation increase the concentration of GLP-1 in the blood? Does DHB supplementation affect appetite, mood, and energy levels? Does DHB supplementation affect body weight, blood sugar control and insulin? Researchers will compare DHB supplementation to a placebo (a look-alike substance that contains no drug) to see if DHB has any effect.
Participants will:
Take DHB or a placebo every day for 6 weeks. Participate in tests to measure GLP-1 levels, blood glucose, insulin and other markers.
Have their continuous blood sugar profiles (with CGMs) monitored to see how much time their blood sugar spends in a healthy range.
Rate their appetite, mood, and energy levels using a visual analog scale.
Eligibility criteria
Qualifiers
None
Disqualifiers
Extreme Diets: Extreme dietary habits (e.g., ketogenic, vegan/vegetarian) at investigator's discretion.
Intense Exercise: Moderate-to-intense physical training (≥5 hours/week).
Weight Instability/Program: Recent weight changes (>4.5 kg≤90 d) or current/planned weight change program.
Abnormal Labs: Abnormal lab test results of clinical significance at Visit 1 (one re-test allowed).
Trial design
Treatments tested in this trial
- Placebo 400 mg
- Dihydroberberine(DHB)400 mg
Treatment groups
Sponsors and collaborators
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Lead sponsor
Biofortis, Merieux NutriSciences
Collaborator