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| Name | Class |
|---|---|
| Biofortis, Merieux NutriSciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Dihydroberberine（DHB） | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-120 minutes post-meal at Baseline and Acute Visit 3, Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight After 6 Weeks of DHB Supplementation | Change in body weight from day 0 to day 42 following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo. | Baseline to End of Study (Day 42), approximately Week 6 |
| Change in Perceived Energy After 6 Weeks of DHB Supplementation |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kotryna Dzekcioriute | Contact | (630) 617-2000 | kotryna.dzekciouriute@mxns.com | |
| Elizabeth Antoo, MD | Contact | (630) 617-2000 | elizabeth.antoo@mxns.com |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Antoo, MD | Biofortis, Inc. Merieux NutriSciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merieux NutriSciences | Recruiting | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35010998 | Result | 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. | |
| 37679692 | Result | 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. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| 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 | Postprandial responses of plasma glucose and insulin during MTT at visit 3, day 0 after single-dose DHB (200 mg) vs. placebo, including:
| 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；
| 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 |
| 24 hours following product intake (Visit 3, Day 0) |
| Mean Glucose and Variability of 24-Hour Continuous Glucose Monitoring (CGM) Glycemic Health Endpoints |
| 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) ：
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. | 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) ：
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:
| 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 |
| 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 |
| 7-day monitoring period before Visit 2 (Day -7) and Visit 4 (Day 42) |
Change in energy VAS rating from day 0 to day 42 following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo. The title of scales is Mental and Physical State Energy and Fatigue State Scales (EFSS). The Energy VAS will be the 6-item Mental and Physical State Energy and Fatigue Scale where participants rate their current subjective feelings of physical and mental energy and fatigue. Energy is a composite score of answers regarding energy, vigor, and pep. Fatigue is a composite score regarding fatigue, exhaustion, and worn-out. Respective individual scores are summed to composite scores ranging from 0 to 300. |
| Baseline to End of Study (Day 42), approximately Week 6 |
| Change in Mood Status After 6 Weeks of DHB Supplementation | Change in Profile of Mood States (POMS) scores from day 0 to day 42 following 6 weeks of daily DHB supplementation (400 mg/day) vs. placebo. The title of scale is Profile of Mood States (POMS). The POMS-2 is a self-report assessment of mood. The POMS-2 can be evaluated for a composite total mood disturbance score and 6 component scores of anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, and vigor-activity. | Baseline to End of Study (Day 42), approximately Week 6 |
| D004700 | Endocrine System Diseases |