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

NCT07210684 | Recruiting

• 1 other identifier: STERLING IRB ID: 14195-EAAntoo
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prediabetes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Postprandial Total GLP-1 Cmax After Single Dose of DHB

  Change in postprandial total glucagon-like peptide-1 (GLP-1) maximum concentration (Cmax) following a single dose of 200 mg DHB compared to placebo, measured at visit 3, day 0.

  Visit 3, Day 0 (after single dose administration)

• Change in GLP-1 Cmax From Baseline to End of Study After 6 Weeks of DHB

  Change in postprandial total GLP-1 maximum concentration (Cmax) from baseline to end of study after 6 weeks of daily supplementation with 400 mg DHB vs. placebo.

  Baseline to End of Study , approximately Week 6

Secondary Outcomes (23)

• Change in Postprandial GLP-1 AUC (piAUC0-120min) After Single Dose of DHB

  0-120 minutes post-meal at Baseline and Acute Visit 3, Day 0

• Change in Time to Maximum Concentration (Tmax) of Postprandial GLP-1 After Single Dose of DHB

  0-120 minutes post-meal at Baseline and Acute Visit 3, Day 0

• Change in Fasting Total GLP-1 Levels from Baseline (day -7) to the Acute Visit 3 (day 0)

  From Baseline (Visit 2, Day -7) to Acute Visit (Visit 3, Day 0)

• Postprandial Glucose and insulin Responses After Single Dose

  0-120 minutes post-meal at Visit 3, Day 0

• Change in Subjective Appetite Perceptions After Single Dose of DHB

  0-120 minutes post-meal at Visit 3, Day 0

Other Outcomes (3)

• Change in Body Weight After 6 Weeks of DHB Supplementation

  Baseline to End of Study (Day 42), approximately Week 6

• Change in Perceived Energy After 6 Weeks of DHB Supplementation

  Baseline to End of Study (Day 42), approximately Week 6

• Change in Mood Status After 6 Weeks of DHB Supplementation

  Baseline to End of Study (Day 42), approximately Week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo 400 mg

Dihydroberberine（DHB）

EXPERIMENTAL

Dietary Supplement: Dihydroberberine（DHB）400 mg

Interventions

Placebo 400 mg DIETARY_SUPPLEMENT

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.

Placebo

Dihydroberberine（DHB）400 mg DIETARY_SUPPLEMENT

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.

Dihydroberberine（DHB）

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• 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).
• Uncontrolled Chronic Illness: Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine (T1D/T2D excluded), hematologic, immunologic, neurologic, psychiatric, or biliary disorders.
• Clinically Important GI: Clinically important GI condition interfering with study product (e.g., IBD, celiac, weight loss surgery history).
• Uncontrolled HTN: Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg).
• Cancer History: History or presence of cancer in the prior 2 years (except non-melanoma skin cancer).
• Active Infection: Signs/symptoms of active infection ≤5 d of Visit 1.
• Anti-Hyperglycemics: Recent use (≤6 mo) of any prescription anti-hyperglycemic medication.
• Other Supplements: Use of dietary supplements (other than approved multivitamin) ≤14 d of Visit 1.
• Alcohol/Substance Abuse: History (≤12 months) of alcohol (\>14 drinks/week) or substance abuse.
• Antibiotics: Antibiotic use ≤90 d of Visit 1.
• Regular NSAIDs: Regular use (≥3 days/week≤30 d) of anti-inflammatory medications.
• Steroid Use: Recent use (≤30 d) of oral/injectable steroids, or high-dose topical/inhaled steroids.

Sponsors & Collaborators

• Nanjing Nutrabuilding Bio-tech Co., Ltd.: lead
• Biofortis, Merieux NutriSciences: collaborator

Study Sites (1)

Merieux NutriSciences

Addison, Illinois, 60101, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 35010998 BACKGROUND

• 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.

  PMID: 37679692 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Antoo, MD

  Biofortis, Inc. Merieux NutriSciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kotryna Dzekcioriute

CONTACT

(630) 617-2000; kotryna.dzekciouriute@mxns.com

Elizabeth Antoo, MD

CONTACT

(630) 617-2000; elizabeth.antoo@mxns.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 7, 2025
• Study Start: August 6, 2025
• Primary Completion: January 15, 2026
• Study Completion: March 15, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)