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| Name | Class |
|---|---|
| Biofortis, Merieux NutriSciences | INDUSTRY |
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The goal of this clinical trial is to evaluate whether dihydroberberine (DHB) supplementation can improve body composition, blood sugar control, energy levels, appetite, and mood in healthy adults with overweight or mild obesity. The study focuses on men and women aged 35-55 years with a BMI between 27.0 and 33.0 kg/m².
The main questions it aims to answer are:
Does daily DHB supplementation lead to greater reductions in body weight over 12 weeks compared to placebo? Does DHB improve glycemic responses, appetite regulation, energy levels, and mood, both acutely (short-term) and chronically (over 12 weeks)?
Researchers will compare two groups-one receiving DHB (400 mg/day) and the other receiving a placebo-administered as two capsules twice daily for 12 weeks. Participants will:
Attend three in-clinic visits over approximately 14 weeks (including screening, baseline, and week 12 visits) Undergo mixed-meal tolerance tests (MTTs) to assess glucose metabolism, appetite, and energy levels Complete body composition assessments (including DXA scans), blood tests (e.g., glucose, insulin, HbA1c), and mood questionnaires (POMS-2) Be monitored for safety throughout the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Dihydroberberine（DHB） | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo （Microcrystalline Cellulose） | Dietary Supplement | Participants will take 4 placebo capsules daily for 12 consecutive weeks, with 2 capsules taken in the morning and 2 in the evening. Each capsule contains 200 mg of microcrystalline cellulose, an inert substance used as an inactive control. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight will be measured in-clinic at Baseline (Visit 2, Week 0, Day 1) and End of Study (Visit 3, Week 12, Day 84) using a calibrated digital scale under standardized conditions (fasted, light clothing, no shoes). | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose Positive Incremental Area Under the Curve (piAUC) | Positive incremental Area Under the Curve (piAUC0-120min) of plasma glucose following a Mixed-meal Tolerance Test (MTT) after a single dose of study product. | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Plasma Glucose Maximum Concentration (Cmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with abnormal Clinical Chemistry Panel (CMP) tests result | Number of participants with CMP analyte values (including albumin, alkaline phosphatase, total bilirubin, direct bilirubin, calcium, chloride, creatinine, BUN, potassium, AST, ALT, sodium, total protein, CO2, and osmolality) that are outside the reference range and considered clinically significant by the investigator. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
Inclusion Criteria:
Exclusion Criteria:
General safety related criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Antoo, MD | Contact | 630-617-2000 | elizabeth.antoo@mxns.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis, Merieux NutriSciences | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35010998 | Background | 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. | |
| 22474499 | Background | Yang J, Yin J, Gao H, Xu L, Wang Y, Xu L, Li M. Berberine improves insulin sensitivity by inhibiting fat store and adjusting adipokines profile in human preadipocytes and metabolic syndrome patients. Evid Based Complement Alternat Med. 2012;2012:363845. doi: 10.1155/2012/363845. Epub 2012 Mar 8. |
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| Dihydroberberine（DHB） | Dietary Supplement | Participants will take 4 capsules daily (each containing 100 mg dihydroberberine [DHB] and 100 mg microcrystalline cellulose) orally for 12 consecutive weeks, with 2 capsules taken in the morning and 2 in the evening. The total daily dose of DHB is 400 mg. |
|
Maximum concentration (Cmax) of plasma glucose following a Mixed-meal Tolerance Test (MTT) after a single dose of study product. |
| Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Plasma Glucose Time to Maximum Concentration (Tmax) | Time to maximum concentration (Tmax) of plasma glucose following a Mixed-meal Tolerance Test (MTT) after a single dose of study product. | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Composite Appetite Score Net Incremental Area Under the Curve (niAUC) | Net incremental Area Under the Curve (niAUC0-120min) for the Composite Appetite Score following a Mixed-meal Tolerance Test (MTT) after a single dose of study product. | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Net Incremental Area Under the Curve (niAUC0-120min) for Individual Appetite Visual Analog Scale (VAS) Ratings | Net incremental area under the curve (niAUC) from 0 to 120 minutes for individual appetite-related sensations measured using a 100-mm Visual Analog Scale (VAS), including Hunger, Desire to Eat, Fullness, and Prospective Food Consumption. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores on Hunger, Desire to Eat, and Prospective Food Consumption indicate greater appetite drive and poorer satiety; higher scores on Fullness indicate greater satiety (better outcome). | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Composite Appetite Score Positive Maximum Response | Maximum positive change from fasting baseline in the Composite Appetite Score, calculated as the average of standardized 100-mm Visual Analog Scale (VAS) ratings for Hunger, Desire to Eat, Fullness, and Prospective Food Consumption. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher values for Hunger, Desire to Eat, and Prospective Food Consumption reflect increased appetite, while higher values for Fullness reflect enhanced satiety; the composite score is interpreted based on the net direction of these opposing components (better outcome). | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Individual Appetite Visual Analog Scale (VAS) Ratings Positive Maximum Response | Maximum positive deviation from fasting baseline in individual appetite-related sensations measured using a 100-mm Visual Analog Scale (VAS) for Hunger, Desire to Eat, Fullness, and Prospective Food Consumption. The scale ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores on Hunger, Desire to Eat, and Prospective Food Consumption represent greater appetite and poorer satiety; higher scores on Fullness represent stronger satiety (better outcome) . | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Energy Composite Score Net Incremental Area Under the Curve (niAUC) | Net incremental area under the curve (niAUC) from 0 to 120 minutes for the Energy Composite Score, derived as the mean of three 100-mm Visual Analog Scale (VAS) items: Energy, Vigor, and Pep. Each VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores indicate greater perceived energy levels and are interpreted as a better outcome. | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Energy Composite Score Positive Maximum Response | Maximum positive change from fasting baseline in the Energy Composite Score, calculated as the average of three 100-mm Visual Analog Scale (VAS) ratings: Energy, Vigor, and Pep. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores reflect greater increases in subjective energy and are considered a better outcome. | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Fatigue Composite Score Net Incremental Area Under the Curve (niAUC) | Net incremental area under the curve (niAUC) from 0 to 120 minutes for the Fatigue Composite Score, calculated as the mean of three 100-mm Visual Analog Scale (VAS) items: Fatigue, Exhaustion, and Worn-out. Each VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores indicate greater perceived fatigue and are interpreted as a worse outcome. | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Fatigue Composite Score Positive Maximum Response | Maximum positive change from fasting baseline in the Fatigue Composite Score, derived from the average of three 100-mm Visual Analog Scale (VAS) ratings: Fatigue, Exhaustion, and Worn-out. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores reflect greater increases in perceived fatigue and are considered a worse outcome. | Baseline (Visit 2, Day 1): t=0 to t=120 minutes |
| Waist Circumference (WC) | Change in in-clinic measured Waist Circumference from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Hip Circumference (HC) | Change in in-clinic measured Hip Circumference from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Waist-to-Hip Ratio (WHR) | Change in calculated Waist-to-Hip Ratio (WC/HC) from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Lean Mass | Change in total and regional (arms, legs, trunk) lean mass, measured via Dual-energy X-ray Absorptiometry (DXA), from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Fat Mass | Change in total and regional (arms, legs, trunk) fat mass, measured via DXA, from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Fat-Free Mass | Change in total fat-free mass, measured via DXA, from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Visceral Adipose Tissue (VAT) | Change in abdominal visceral fat mass and volume, measured via DXA, from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Fasting Plasma Glucose | Change in fasting plasma glucose levels from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Fasting Plasma Insulin | Change in fasting plasma insulin levels from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Glycated Hemoglobin (HbA1c) | Change in Glycated Hemoglobin (HbA1c) levels from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Change in HOMA-IR calculated from fasting glucose and insulin levels from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Fasting Plasma Leptin | Change in fasting plasma leptin levels from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Postprandial Glucose niAUC (0-120 min) | Change in postprandial glucose niAUC (0-120 min) response to an MTT from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Postprandial Glucose Cmax | Change in postprandial glucose Cmax response to an MTT from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Postprandial Glucose Tmax | Change in postprandial glucose Tmax response to an MTT from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Postprandial Appetite Visual Analog Scale (VAS) Net Incremental Area Under the Curve (niAUC; 0-120 minutes) | Change from baseline to end of study in the net incremental area under the curve (niAUC) over 0 to 120 minutes for postprandial appetite ratings measured using a 100-mm Visual Analog Scale (VAS), including Hunger, Desire to Eat, Fullness, and Prospective Food Consumption. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores on Hunger, Desire to Eat, and Prospective Food Consumption indicate greater appetite drive and poorer satiety ; higher scores on Fullness indicate greater satiety (better outcome). | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Postprandial Appetite Visual Analog Scale (VAS) Positive Maximum Response | Change from baseline to end of study in the positive maximum response (maximum increase from fasting value) of postprandial appetite ratings measured using a 100-mm Visual Analog Scale (VAS), including Hunger, Desire to Eat, Fullness, and Prospective Food Consumption. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores on Hunger, Desire to Eat, and Prospective Food Consumption indicate greater appetite drive and poorer satiety; higher scores on Fullness indicate greater satiety (better outcome). | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Postprandial Energy Visual Analog Scale (VAS) Net Incremental Area Under the Curve (niAUC; 0-120 min) | Change from baseline to end of study in the net incremental area under the curve (niAUC) over 0-120 minutes for postprandial energy-related ratings measured using a 100-mm Visual Analog Scale (VAS), including Energy, Vigor, and Pep. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher niAUC values indicate greater postprandial energy enhancement and are interpreted as a better outcome. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Postprandial Energy Visual Analog Scale (VAS) Positive Maximum Response | Change from baseline (Week 0) to end of study (Week 12) in the incremental peak response (defined as the maximum increase from the pre-meal fasting value) for postprandial energy-related ratings. Ratings are assessed using a 100-mm Visual Analog Scale (VAS) for three items: Energy, Vigor, and Pep. The VAS ranges from 0 mm ("not at all") to 100 mm ("extremely"). Higher scores represent a greater maximal increase in perceived energy levels, indicating a better outcome. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Profile of Mood States -2 (POMS-2) Total and Component Scores | Change from baseline to end of study in the POMS-2 Total Mood Disturbance (TMD) score and six component subscale scores: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, and Vigor-Activity. The POMS-2 is a validated 65-item self-report questionnaire rated on a 5-point Likert scale (0 = "Not at all" to 4 = "Extremely"). The TMD score is calculated by summing the scores of the five negative mood subscales and subtracting the Vigor-Activity score. Higher TMD and negative subscale scores reflect greater emotional distress (worse outcome), while higher Vigor-Activity scores reflect increased energy and well-being (better outcome). | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Number of participants with abnormal Complete Blood Count (CBC) tests result | Number of participants with CBC analyte values (including WBC, RBC, hemoglobin concentration, hematocrit, MCV, MCH, MCHC, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelet count) that are outside the reference range and considered clinically significant by the investigator. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Blood Pressure | Change in resting systolic blood pressure and diastolic blood pressure from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Heart Rate | Change in resting heart rate from Baseline to the End of the Study. | Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence, type, severity, and relationship to the study product of AEs and SAEs occurring during the chronic phase. | Start of study product consumption (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84) |
| 19800084 | Background | Zhang H, Wei J, Xue R, Wu JD, Zhao W, Wang ZZ, Wang SK, Zhou ZX, Song DQ, Wang YM, Pan HN, Kong WJ, Jiang JD. Berberine lowers blood glucose in type 2 diabetes mellitus patients through increasing insulin receptor expression. Metabolism. 2010 Feb;59(2):285-92. doi: 10.1016/j.metabol.2009.07.029. Epub 2009 Oct 1. |
| 34931749 | Background | Chan M, Qin Z, Man SC, Lam M, Lai WH, Ng RMK, Lee CK, Wong TL, Lee EHM, Wong HK, Feng Y, Liu L, Han F, Chen EYH, Zhang ZJ. Adjunctive berberine reduces antipsychotic-associated weight gain and metabolic syndrome in patients with schizophrenia: a randomized controlled trial. Psychiatry Clin Neurosci. 2022 Mar;76(3):77-85. doi: 10.1111/pcn.13323. Epub 2022 Jan 18. |