Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes

ConditionPrediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorNanjing Nutrabuilding Bio-tech Co., Ltd.

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

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Nanjing Nutrabuilding Bio-tech Co., Ltd.

Lead sponsor

Biofortis, Merieux NutriSciences

Collaborator