Dihydroberberine (DHB) to raise GLP-1 and help blood sugar, appetite, and mood in adults with prediabetes

A Randomized, Double-Blind, Placebo-Controlled Trial on the Effects of Dihydroberberine (DHB) on Glucagon-Like Peptide-1 (GLP-1), Glycemic Control, and Subjective Rating of Appetite and Mood/Energy in Adults With Pre-Diabetes

This will try daily Dihydroberberine (DHB) pills for six weeks in adults with prediabetes to see if DHB raises GLP-1 and improves blood sugar control, appetite, energy, and mood compared with a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 35 Years to 65 Years
• Sex: All
• Sponsor: Nanjing Nutrabuilding Bio-tech Co., Ltd. (Academic / other)
• Locations: 1 site (Addison, Illinois)
• Trial ID: NCT07210684 on ClinicalTrials.gov

What this trial studies

Adults with prediabetes (age 35–65, BMI 25–35 kg/m2, HbA1c 5.7–6.4%) will take 400 mg DHB or a matching placebo daily for six weeks and undergo blood tests and continuous glucose monitoring. Primary measures include circulating GLP-1 levels, glycemic outcomes (CGM time-in-range, fasting glucose, insulin), body weight, and patient-reported appetite, mood, and energy using visual analog scales. The protocol compares DHB to placebo to determine short-term metabolic and behavioral effects. Study visits and sample collection occur at a contract research site (Merieux NutriSciences, Addison, Illinois) and participants must use compatible smartphone apps for diet logs and CGM data.

Who should consider this trial

Good fit: Ideal candidates are adults 35–65 years old with BMI 25–35 kg/m2 and HbA1c 5.7–6.4% who can wear a CGM, use required smartphone apps, and abstain from habitual nicotine or daily cannabis during the study.

Not a fit: People with established diabetes, outside the specified age/BMI/HbA1c ranges, unable to use a CGM or the required apps, pregnant or breastfeeding, or taking GLP-1 or other diabetes medications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, DHB could offer a non-prescription supplement approach to boost GLP-1 and modestly improve blood sugar control, appetite, or mood for people with prediabetes.

How similar studies have performed: Related compounds such as berberine have shown modest glucose-lowering effects in small trials, but DHB itself is relatively novel with limited clinical data.

Eligibility criteria

Inclusion Criteria:

1.35 - 65 years of age (inclusive). 2.BMI 25.0 - 35.0 kg/m2 (inclusive). 3.HbA1c 5.7% - 6.4% (39 - 47 mmol/mol, inclusive) measured at visit 1. 4.Participant has a score of 7 - 10 on the Vein Access Scale Assessment at visit 1.

5.Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.

6.Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).

7.Willing to wear a CGM sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.

8.Willing to use personal smart phone with operating system capable of downloading and operating the Cronometer and Dexcom CGM apps for diet records and blood glucose, respectively.

9.Willing to adhere to all study procedures, including lifestyle considerations, and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

Exclusion Criteria:

1. Extreme Diets: Extreme dietary habits (e.g., ketogenic, vegan/vegetarian) at investigator's discretion.
2. Intense Exercise: Moderate-to-intense physical training (≥5 hours/week).
3. Weight Instability/Program: Recent weight changes (\>4.5 kg≤90 d) or current/planned weight change program.
4. Abnormal Labs: Abnormal lab test results of clinical significance at Visit 1 (one re-test allowed).
5. Uncontrolled Chronic Illness: Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine (T1D/T2D excluded), hematologic, immunologic, neurologic, psychiatric, or biliary disorders.
6. Clinically Important GI: Clinically important GI condition interfering with study product (e.g., IBD, celiac, weight loss surgery history).
7. Uncontrolled HTN: Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg).
8. Cancer History: History or presence of cancer in the prior 2 years (except non-melanoma skin cancer).
9. Active Infection: Signs/symptoms of active infection ≤5 d of Visit 1.
10. Anti-Hyperglycemics: Recent use (≤6 mo) of any prescription anti-hyperglycemic medication.
11. Other Supplements: Use of dietary supplements (other than approved multivitamin) ≤14 d of Visit 1.
12. Alcohol/Substance Abuse: History (≤12 months) of alcohol (\>14 drinks/week) or substance abuse.
13. Antibiotics: Antibiotic use ≤90 d of Visit 1.
14. Regular NSAIDs: Regular use (≥3 days/week≤30 d) of anti-inflammatory medications.
15. Steroid Use: Recent use (≤30 d) of oral/injectable steroids, or high-dose topical/inhaled steroids.
16. Unregistered Drug: Exposure to any non-registered drug product ≤30 d prior to Visit 1
17. Medication Instability: Unstable dose (≤90 d) of any other prescription medications (PRN excluded).
18. Psychiatric Hospitalization: Major affective/psychiatric disorder requiring hospitalization ≤12 months prior to Visit 1.
19. Recent Trauma/Surgery: Major trauma or any surgical event ≤30 d of Visit 1.
20. Recent GI Prep: Endoscopy or colonoscopy preparation ≤90 d prior to Visit 1.
21. Planned Surgery: Scheduled or planning elective surgical procedures during the study.
22. Female Status: Pregnancy, lactation, planning pregnancy, or unwillingness to use approved contraception.
23. Allergies: Known sensitivity or allergy to any study products or foods.
24. Investigator Discretion: Any condition that interferes with compliance, confounds results, or presents undue risk.

Where this trial is running

Addison, Illinois

• Merieux NutriSciences — Addison, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Elizabeth Antoo, MD — Biofortis, Inc. Merieux NutriSciences
• Study coordinator: Kotryna Dzekcioriute

Conditions Prediabetes; GlucoVantage®; DHB; Dihydroberberine; GLP-1; Glucagon-Like Peptide-1; Blood glucose; Appetite and Mood/Energy