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.
None
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).
Parallel
Placebo 400 mg
Dietary supplementParticipants will receive 4 placebo capsules daily for 6 weeks. Each capsule contains 100 mg of microcrystalline cellulose, which serves as a inactive control substance.
Dihydroberberine（DHB）400 mg
Dietary supplementParticipants will receive 4 capsules of DHB (Dihydroberberine) 100 mg each, orally, once daily for 6 weeks. The total daily dose is 400 mg of DHB.
Change in Postprandial Total GLP-1 Cmax After Single Dose of DHB
Change in postprandial total glucagon-like peptide-1 (GLP-1) maximum concentration (Cmax) following a single dose of 200 mg DHB compared to placebo, measured at visit 3, day 0.
Change in GLP-1 Cmax From Baseline to End of Study After 6 Weeks of DHB
Change in postprandial total GLP-1 maximum concentration (Cmax) from baseline to end of study after 6 weeks of daily supplementation with 400 mg DHB vs. placebo.
Change in Postprandial GLP-1 AUC (piAUC0-120min) After Single Dose of DHB
Positive incremental AUC (piAUC0-120min) as calculated by the linear trapezoid method where the fasting levels will be subtracted from post-product consumption time points and levels lower than baseline will be truncated at 0
Change in Time to Maximum Concentration (Tmax) of Postprandial GLP-1 After Single Dose of DHB
Change in Fasting Total GLP-1 Levels from Baseline (day -7) to the Acute Visit 3 (day 0)
Postprandial Glucose and insulin Responses After Single Dose
Postprandial responses of plasma glucose and insulin during MTT at visit 3, day 0 after single-dose DHB (200 mg) vs. placebo, including: 1. maximum concentration (Cmax)； 2. time to peak (Tmax)； 3. positive incremental AUC (piAUC0-120min)； 4. fasting levels.
Change in Body Weight After 6 Weeks of DHB Supplementation
Change in body weight from day 0 to day 42 following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo.
Change in Perceived Energy After 6 Weeks of DHB Supplementation
Change in energy VAS rating from day 0 to day 42 following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo. The title of scales is Mental and Physical State Energy and Fatigue State Scales (EFSS). The Energy VAS will be the 6-item Mental and Physical State Energy and Fatigue Scale where participants rate their current subjective feelings of physical and mental energy and fatigue. Energy is a composite score of answers regarding energy, vigor, and pep. Fatigue is a composite score regarding fatigue, exhaustion, and worn-out. Respective individual scores are summed to composite scores ranging from 0 to 300.
Change in Mood Status After 6 Weeks of DHB Supplementation
Change in Profile of Mood States (POMS) scores from day 0 to day 42 following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo. The title of scale is Profile of Mood States (POMS). The POMS-2 is a self-report assessment of mood. The POMS-2 can be evaluated for a composite total mood disturbance score and 6 component scores of anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity.
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Nanjing Nutrabuilding Bio-tech Co., Ltd.
Lead sponsor
Biofortis, Merieux NutriSciences
Collaborator
