DHB
RecruitingPhase NAEffects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes
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
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
1
Estimated enrollment
54
Study population
-
Eligibility highlights
•BMI 25-35•HbA1c 5.7-6.4%
Primary endpoints
•Postprandial Total GLP-1 Cmax After Single Dose of DHB•GLP-1 Cmax
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who can enroll
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.
Endpoints (28)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChange in Body Weight After 6 Weeks of DHB Supplementation
Time frame:Baseline to End of Study (Day 42), approximately Week 6
change from baseline, improvement
Glycemic / diabetes
14 endpointsPostprandial Glucose and insulin Responses After Single Dose
Time frame:0-120 minutes post-meal at Visit 3, Day 0
descriptive
Time In/Out of Range of 24-Hour Continuous Glucose Monitoring (CGM) Glycemic Health Endpoints
Time frame:24 hours following product intake (Visit 3, Day 0)
descriptive
Mean Glucose and Variability of 24-Hour Continuous Glucose Monitoring (CGM) Glycemic Health Endpoints
Time frame:24 hours following product intake (Visit 3, Day 0)
descriptive
Change in Postprandial Plasma Glucose Maximum Concentration (Cmax) from Baseline After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Postprandial Plasma Glucose Time to Peak Concentration (Tmax) from Baseline After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Postprandial Plasma Glucose Positive Incremental Area Under the Curve (piAUC0-120min) from Baseline After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Fasting Plasma Glucose Levels from Baseline to Week 6
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Postprandial Plasma Insulin Time to Peak Concentration (Tmax) from Baseline After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Postprandial Plasma Insulin Positive Incremental Area Under the Curve (piAUC0-120min) from Baseline After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Fasting Plasma Insulin Levels from Baseline to Week 6
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) After 6 Weeks
Time frame:Baseline (Visit 2) to End of Study (Visit 4), approximately Week 6
change from baseline, improvement
Change in Postprandial Insulin Maximum Concentration (Cmax) from Baseline to Week 6
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Time In/Out of Range of 7-Day Continuous Glucose Monitoring (CGM) Parameters After 6 Weeks
Time frame:7-day monitoring period before Visit 2 (Day -7) and Visit 4 (Day 42)
descriptive
Mean Glucose Averaged and Variability of Over 7 Days from Baseline to Week 6
Time frame:7-day monitoring period before Visit 2 (Day -7) and Visit 4 (Day 42)
descriptive
Safety / tolerability / PK
5 endpointsChange in Postprandial Total GLP-1 Cmax After Single Dose of DHB
Time frame:Visit 3, Day 0 (after single dose administration)
change from baseline, event
Change in GLP-1 Cmax From Baseline to End of Study After 6 Weeks of DHB
Time frame:Baseline to End of Study , approximately Week 6
change from baseline, event
Change in Postprandial GLP-1 AUC (piAUC0-120min) After Single Dose of DHB
Time frame:0-120 minutes post-meal at Baseline and Acute Visit 3, Day 0
change from baseline, event
Change in Time to Maximum Concentration (Tmax) of Postprandial GLP-1 After Single Dose of DHB
Time frame:0-120 minutes post-meal at Baseline and Acute Visit 3, Day 0
change from baseline, event
Change in Postprandial Total GLP-1 Time to Maximum Concentration (Tmax) from Baseline to Week 6
Time frame:Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, event
Other (unclassified)
8 endpointsChange in Fasting Total GLP-1 Levels from Baseline (day -7) to the Acute Visit 3 (day 0)
Time frame:From Baseline (Visit 2, Day -7) to Acute Visit (Visit 3, Day 0)
change from baseline, improvement
Change in Subjective Appetite Perceptions After Single Dose of DHB
Time frame:0-120 minutes post-meal at Visit 3, Day 0
change from baseline, improvement
Change in Postprandial GLP-1 (piAUC0-120min) After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Fasting Plasma Total GLP-1 Levels from Baseline to Week 6
Time frame:Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Appetite Perceptions for composite VAS ratings After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Appetite Perceptions for individual VAS ratings After 6 Weeks of Supplementation
Time frame:Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
change from baseline, improvement
Change in Perceived Energy After 6 Weeks of DHB Supplementation
Time frame:Baseline to End of Study (Day 42), approximately Week 6
change from baseline, improvement
Change in Mood Status After 6 Weeks of DHB Supplementation
Time frame:Baseline to End of Study (Day 42), approximately Week 6
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.