Actively Recruiting
Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes
Led by Nanjing Nutrabuilding Bio-tech Co., Ltd. · Updated on 2025-10-07
54
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
N
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Lead Sponsor
B
Biofortis, Merieux NutriSciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 35 to 65 years of age (inclusive)
- Body mass index (BMI) between 25.0 and 35.0 kg/m2 (inclusive)
- HbA1c level between 5.7% and 6.4% measured at visit 1
- Vein Access Scale Assessment score between 7 and 10 at visit 1
- Non-user or former user of tobacco or nicotine products for at least 12 months prior to visit 1, with no plans to start during the study
- Non-habitual user of marijuana or hemp products and willing to abstain during the study (topical products allowed)
- Willingness to wear a continuous glucose monitor (CGM) throughout the study
- Willingness to use a smartphone capable of running Cronometer and Dexcom CGM apps
- Willingness to follow all study procedures, lifestyle considerations, and provide informed consent
You will not qualify if you...
- Extreme dietary habits (e.g., ketogenic, vegan/vegetarian) as determined by the investigator
- Moderate-to-intense physical exercise 5 or more hours per week
- Recent weight changes greater than 4.5 kg within the last 90 days or current/planned weight change program
- Abnormal lab test results of clinical significance at visit 1 (one retest allowed)
- Uncontrolled or clinically important chronic illnesses including pulmonary, cardiac, hepatic, renal, endocrine (except type 1 or type 2 diabetes), hematologic, immunologic, neurologic, psychiatric, or biliary disorders
- Clinically important gastrointestinal conditions that interfere with the study product (e.g., inflammatory bowel disease, celiac disease, history of weight loss surgery)
- Uncontrolled hypertension with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg
- History or presence of cancer within the past 2 years (except non-melanoma skin cancer)
- Signs or symptoms of active infection within 5 days of visit 1
- Use of prescription anti-hyperglycemic medication within 6 months prior to visit 1
- Use of dietary supplements other than approved multivitamins within 14 days prior to visit 1
- History of alcohol abuse (>14 drinks/week) or substance abuse within 12 months
- Use of antibiotics within 90 days prior to visit 1
- Regular use of anti-inflammatory medications at least 3 days per week for 30 days
- Use of oral/injectable steroids or high-dose topical/inhaled steroids within 30 days
- Exposure to any non-registered drug product within 30 days prior to visit 1
- Unstable dose of any prescription medication within 90 days (excluding as-needed medications)
- Major psychiatric hospitalization within 12 months prior to visit 1
- Major trauma or surgery within 30 days prior to visit 1
- Endoscopy or colonoscopy preparation within 90 days prior to visit 1
- Planned elective surgery during the study period
- Pregnancy, lactation, planning pregnancy, or unwillingness to use approved contraception
- Known allergy or sensitivity to any study products or foods
- Any condition that may interfere with compliance, confound results, or present undue risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Merieux NutriSciences
Addison, Illinois, United States, 60101
Actively Recruiting
Research Team
K
Kotryna Dzekcioriute
CONTACT
E
Elizabeth Antoo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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