PrediabetesDHBNCT07210684
Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes
A study testing Dihydroberberine（DHB）400 mg in people with Prediabetes, run by Nanjing Nutrabuilding Bio-tech Co., Ltd. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Dihydroberberine（DHB）400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Unregistered Drug: Exposure to any non-registered drug product ≤30 d prior to Visit 1
- Medication Instability: Unstable dose (≤90 d) of any other prescription medications (PRN excluded).
- Psychiatric Hospitalization: Major affective/psychiatric disorder requiring hospitalization ≤12 months prior to Visit 1.
- Recent Trauma/Surgery: Major trauma or any surgical event ≤30 d of Visit 1.
- Recent GI Prep: Endoscopy or colonoscopy preparation ≤90 d prior to Visit 1.
- Planned Surgery: Scheduled or planning elective surgical procedures during the study.
- Female Status: Pregnancy, lactation, planning pregnancy, or unwillingness to use approved contraception.
- Allergies: Known sensitivity or allergy to any study products or foods.
- Investigator Discretion: Any condition that interferes with compliance, confounds results, or presents undue risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Merieux NutriSciences
Addison, Illinois, 60101
Elizabeth Antoo, MD, (630) 617-2000, elizabeth.antoo@mxns.com
About this study
Official title: 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
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:
Read more
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
- Being tested
- Placebo 400 mg, Dihydroberberine（DHB）400 mg
- Keywords
- GlucoVantage®, DHB, Dihydroberberine, GLP-1, Glucagon-Like Peptide-1, Blood glucose, Appetite and Mood/Energy
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo 400 mgDietary 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.
Dihydroberberine（DHB）400 mgDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo 400 mg |
| Dihydroberberine（DHB） | Experimental | Not described Receives: Dietary Supplement: Dihydroberberine（DHB）400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to End of Study , approximately Week 6
Secondary outcomes (23)
Change in Postprandial GLP-1 AUC (piAUC0-120min) After Single Dose of DHB
Positive incremental AUC (piAUC0-120min) as calculated by the linear trapezoid method where the fasting levels will be subtracted from post-product consumption time points and levels lower than baseline will be truncated at 0
Measured: 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
Measured: 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)
Measured: From Baseline (Visit 2, Day -7) to Acute Visit (Visit 3, Day 0)
Postprandial Glucose and insulin Responses After Single Dose
Postprandial responses of plasma glucose and insulin during MTT at visit 3, day 0 after single-dose DHB (200 mg) vs. placebo, including:
- maximum concentration (Cmax)；
- time to peak (Tmax)；
- positive incremental AUC (piAUC0-120min)；
- fasting levels.
Measured: 0-120 minutes post-meal at Visit 3, Day 0
Change in Subjective Appetite Perceptions After Single Dose of DHB
Appetite VAS ratings quantified by the following metrics： （1）0-120 min net incremental AUC (niAUC0-120min) as calculated by the linear trapezoid method where the baseline values (measured at t = -45 min) will be subtracted from post product consumption time points；
- Composite appetite score ([desire to eat + hunger + (100 - fullness) + prospective consumption]/4)；
- Individual VAS ratings: Hunger; Desire to eat; Fullness; Prospective food consumption ； （2）Positive maximum response (i.e., change from the fasted value t = -45 min) appetite for composite and individual VAS ratings； （3）Fasting (t = -45 min) appetite for composite and individual VAS ratings；
Measured: 0-120 minutes post-meal at Visit 3, Day 0
Time In/Out of Range of 24-Hour Continuous Glucose Monitoring (CGM) Glycemic Health Endpoints
- Time In Range (TIR) and percentage of TIR where the target range is 70 - 180 mg/dL；
- Time In Tight Range (TITR) and percentage of TITR where the tight target range is 70 - 140 mg/dL ；
- Time above range and the percentage of readings >180 mg/dL ；
- Time below range and the percentage of readings < 70 mg/dL.
Measured: 24 hours following product intake (Visit 3, Day 0)
Mean Glucose and Variability of 24-Hour Continuous Glucose Monitoring (CGM) Glycemic Health Endpoints
- Change in Mean 24-Hour Glucose: Mean glucose averaged over the 24 collection period；
- Glycemic Variability (Coefficient of Variation (CV) ): Glycemic variability defined by the Standard Deviation (SD) and CV over the 24 h collection period.
Measured: 24 hours following product intake (Visit 3, Day 0)
Change in Postprandial GLP-1 (piAUC0-120min) After 6 Weeks of Supplementation
Change in positive incremental area under the curve (piAUC0-120min) for plasma total GLP-1 during the Meal Tolerance Test (MTT) from baseline (Visit 2, Day -7) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, calculated using the linear trapezoidal method.
Measured: Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Postprandial Total GLP-1 Time to Maximum Concentration (Tmax) from Baseline to Week 6
Change in the Time to Tmax of plasma total GLP-1 during the MTT from baseline (Visit 2, Day -7) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo
Measured: Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Fasting Plasma Total GLP-1 Levels from Baseline to Week 6
Change in fasting plasma total GLP-1 levels from baseline (Visit 2, Day -7) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo.
Measured: Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Postprandial Plasma Glucose Maximum Concentration (Cmax) from Baseline After 6 Weeks of Supplementation
Change in plasma glucose dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Postprandial Plasma Glucose Time to Peak Concentration (Tmax) from Baseline After 6 Weeks of Supplementation
Change in plasma glucose dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Postprandial Plasma Glucose Positive Incremental Area Under the Curve (piAUC0-120min) from Baseline After 6 Weeks of Supplementation
Change in plasma glucose dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Fasting Plasma Glucose Levels from Baseline to Week 6
Change in plasma glucose dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Postprandial Plasma Insulin Time to Peak Concentration (Tmax) from Baseline After 6 Weeks of Supplementation
Change in plasma insulin dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Postprandial Plasma Insulin Positive Incremental Area Under the Curve (piAUC0-120min) from Baseline After 6 Weeks of Supplementation
Change in plasma insulin dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Fasting Plasma Insulin Levels from Baseline to Week 6
Change in plasma insulin dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) After 6 Weeks
Change in insulin resistance index from baseline (Visit 2) to end of study (Visit 4) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo. HOMA-IR is calculated as [fasting insulin (mU/L) × fasting glucose (mg/dL)] / 405.
Measured: Baseline (Visit 2) to End of Study (Visit 4), approximately Week 6
Change in Postprandial Insulin Maximum Concentration (Cmax) from Baseline to Week 6
Change in plasma insulin dynamics from baseline (Visit 2, day 0) to end of study (Visit 4, Day 42) following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo, assessed during the MTT.
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Appetite Perceptions for composite VAS ratings After 6 Weeks of Supplementation
Change in appetite VAS ratings from baseline (Visit 2) to the end of study (Visit 4) ：
- niAUC0-120min appetite for composite VAS ratings
- Positive maximum response appetite for composite VAS ratings
- Fasting appetite for composite VAS ratings
The Appetite Visual Analog Scale (VAS) is used to assess subjective feelings of appetite. This VAS contains four questions related to appetite (hunger, desire to eat, fullness, and prospective food consumption). The scores are interpreted as follows: composite appetite where lower scores indicate less appetite; hunger where lower scores indicate less hunger; desire to eat where lower scores indicate less desire to eat; fullness where high scores indicate more fullness; prospective food consumption where lower scores indicate less prospective food consumption.
Measured: Baseline (Visit 2, Day -7) to End of Study (Visit 4, Day 42), approximately Week 6
Change in Appetite Perceptions for individual VAS ratings After 6 Weeks of Supplementation
Change in appetite VAS ratings from baseline (Visit 2) to the end of study (Visit 4) ：
- niAUC0-120min appetite for individual VAS ratings
- Positive maximum response appetite for individual VAS ratings
- Fasting appetite for individual VAS ratings
The Appetite Visual Analog Scale (VAS) is used to assess subjective feelings of appetite. The scale consists of a continuous line that ranges from 0 to 100 mm.
The four specific scale items assessed during the MTT are:
- How hungry do you feel? (Anchor: 0 = Not hungry at all; 100 = As hungry as I have ever felt)
- How strong is your desire to eat? (Anchor: 0 = Not strong at all; 100 = As strong as I have ever felt)
- How full do you feel? (Anchor: 0 = Not full at all; 100 = As full as I have ever felt)
- How much food do you think you can eat? (Anchor: 0 = Nothing at all; 100 = A large amount)
Measured: Baseline (Visit 2, day 0) to End of Study (Visit 4, Day 42), approximately Week 6
Time In/Out of Range of 7-Day Continuous Glucose Monitoring (CGM) Parameters After 6 Weeks
- Time In Range (TIR) and percentage of TIR where the target range is 70 - 180 mg/dL；
- Time In Tight Range (TITR) and percentage of TITR where the tight target range is 70 - 140 mg/dL；
- Time above range and the percentage of readings >180 mg/dL；
- Time below range and the percentage of readings <70 mg/dL.
Measured: 7-day monitoring period before Visit 2 (Day -7) and Visit 4 (Day 42)
Mean Glucose Averaged and Variability of Over 7 Days from Baseline to Week 6
- Mean glucose averaged over the 7-day collection period；
- Glycemic variability defined by the SD and CV over the 7-day collection period.
Measured: 7-day monitoring period before Visit 2 (Day -7) and Visit 4 (Day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start6 Aug 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Nutrabuilding Bio-tech Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Biofortis, Merieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Elizabeth Antoo, MD, Principal investigator, Biofortis, Inc. Merieux NutriSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210684
- Sponsor's protocol ID
- STERLING IRB ID: 14195-EAAntoo
- Acronym
- DHB
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35010998Panigrahi 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.
PubMed 37679692
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07210684
- Acronym / sponsor ID
- DHB / STERLING IRB ID: 14195-EAAntoo
- Conditions
- Prediabetes
- Keywords
- GlucoVantage®, DHB, Dihydroberberine, GLP-1, Glucagon-Like Peptide-1, Blood glucose, Appetite and Mood/Energy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Nanjing Nutrabuilding Bio-tech Co., Ltd.University, hospital or other
- Collaborators
- Biofortis, Merieux NutriSciences
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo 400 mg |
| Dihydroberberine（DHB） | Experimental | Dietary Supplement: Dihydroberberine（DHB）400 mg |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo 400 mgParticipants will receive 4 placebo capsules daily for 6 weeks. Each capsule contains 100 mg of microcrystalline cellulose, which serves as a inactive control substance. | Dietary supplement | Placebo |
| Dihydroberberine（DHB）400 mgParticipants 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. | Dietary supplement | Dihydroberberine（DHB） |
Primary outcome
Change in Postprandial Total GLP-1 Cmax After Single Dose of DHB
Time frame: Visit 3, Day 0 (after single dose administration)
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.
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 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.
23 secondary outcomes
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 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 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)
Postprandial Glucose and insulin Responses After Single Dose
Time frame: 0-120 minutes post-meal at Visit 3, Day 0
Change in Subjective Appetite Perceptions After Single Dose of DHB
Time frame: 0-120 minutes post-meal at Visit 3, Day 0
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)
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)
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 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 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 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 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 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 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 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 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 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 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 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 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 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
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publication: PubMed 35010998Moon 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.
- Results publication: PubMed 37679692Panigrahi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Antoo, MD principal investigator
Biofortis, Inc. Merieux NutriSciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dihydroberberine（DHB）400 mg in people with Prediabetes, run by Nanjing Nutrabuilding Bio-tech Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kotryna Dzekcioriute ((630) 617-2000, kotryna.dzekciouriute@mxns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postprandial Total GLP-1 Cmax After Single Dose of DHB (time frame: Visit 3, Day 0 (after single dose administration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210684, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.