Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes
NCT ID: NCT07210684
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2025-08-06
2026-03-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Placebo
Placebo 400 mg
Participants 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）
Dihydroberberine（DHB）400 mg
Participants 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.
Interventions
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Placebo 400 mg
Participants 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
Participants 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
65 Years
ALL
No
Sponsors
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Biofortis, Merieux NutriSciences
INDUSTRY
Nanjing Nutrabuilding Bio-tech Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Antoo, MD
Role: PRINCIPAL_INVESTIGATOR
Biofortis, Inc. Merieux NutriSciences
Locations
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Merieux NutriSciences
Addison, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Moon JM, Ratliff KM, Hagele AM, Stecker RA, Mumford PW, Kerksick CM. Absorption Kinetics of Berberine and Dihydroberberine and Their Impact on Glycemia: A Randomized, Controlled, Crossover Pilot Trial. Nutrients. 2021 Dec 28;14(1):124. doi: 10.3390/nu14010124.
Panigrahi A, Mohanty S. Efficacy and safety of HIMABERB(R) Berberine on glycemic control in patients with prediabetes: double-blind, placebo-controlled, and randomized pilot trial. BMC Endocr Disord. 2023 Sep 7;23(1):190. doi: 10.1186/s12902-023-01442-y.
Other Identifiers
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STERLING IRB ID: 14195-EAAntoo
Identifier Type: -
Identifier Source: org_study_id
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