Health Adult SubjectsDHBNCT07322679
Dihydroberberine Effects on Body Composition and Metabolic Health in Healthy Adults
A study testing Dihydroberberine（DHB） in people with Health Adult Subjects, run by Nanjing Nutrabuilding Bio-tech Co., Ltd. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- Dihydroberberine（DHB）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 25 Sep 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 35 - 55 years of age (inclusive) at visit 1.
- BMI ≥ 27.0 - ≤ 33.0 kg/m2.
- 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 use personal smart phone with operating system capable of downloading and operating study applications (e.g., FitBit, smart scale, activity watch, etc).
- Willing to adhere to all study procedures, including lifestyle considerations (see section 6.3), 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 dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
- Individuals undergoing moderate-to-intense activity (e.g., sports/exercise ≥ 5h/wk).
- Recent weight changes (>4.5 kg ≤ 90 d of visit 1), or current/planned engagement in a weight change program (e.g., weight loss or muscle gain) outside of the researcher-instructed, self-directed Lifestyle Intervention throughout the study period.
- Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for subjects with abnormal laboratory test results.
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
- Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies).
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- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. Stable use (no initiation or change in dose ≤ 90 d of visit 1) of FDA-approved medications for hypertension is allowed.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Signs or symptoms of an active infection of clinical relevance ≤ 5 d of visit 1. The visit may be rescheduled once all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to visit 1.
- Recent use (≤ 6 mo of visit 1) of any prescription anti-hyperglycemic/weight loss medication. This includes, but is not limited to: metformin, insulin, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 agonist, GIP agonists, Pioglitazone and Sulfonylureas.
- Use of any dietary supplement, other than conventional once-daily multivitamin/mineral supplements (within limits of the DRI) ≤ 14 d of visit 1 and throughout the study.
- Recent history (≤ 12 months visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Unstable use (change in dose) of any other prescription medications ≤ 90 d of visit 1, except for medications used PRN (e.g., asthma inhalers, non-drowsy seasonal allergy medications, etc.)
- Antibiotic use ≤ 90 d of visit 1 and throughout the study period.
- Regular use (≥ 3 days/week ≤ 30 d of visit 1) of anti-inflammatory medications (e.g., NSAIDs) and throughout the study period.
- Recent use of oral or injectable steroids, or topical or inhaled steroids (≥ 1500 µg/d) within 30 d of visit 1 and throughout the study period.
- Exposure to any non-registered drug product ≤ 30 d prior to visit 1.
- Diagnosed with major affective disorder, or other psychiatric disorder, that required hospitalization ≤ 12 months prior to visit 1.
- Recent (≤ 90 d of visit 1) endoscopy and/or colonoscopy procedure.
- Major trauma or any other surgical event ≤ 30 d of visit 1.
- Currently scheduled, or planning to schedule, an elective surgical procedure during the study.
- Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. Women who become pregnant during the study will be discontinued.
- General safety related criteria
- Known sensitivity, intolerability, or allergy to any of the study products or study foods.
- Has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, and comply with the study protocol, which might confound the interpretation of the study results, or put the participant at 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
Biofortis, Merieux NutriSciences
Addison, Illinois, 60101
Elizabeth Antoo, MD, 630-617-200, elizabeth.antoo@mxns.com
About this study
Official title: Effects of Dihydroberberine Supplementation on Body Composition, Glycemic Control, Energy Levels, Appetite, and Mood in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
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:
Read more
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
- Conditions
- Health Adult Subjects
- Being tested
- Placebo （Microcrystalline Cellulose）, Dihydroberberine（DHB）
- Keywords
- Glucovantage®, DHB, Dihydroberberine, Body Composition, Glycemic Control, Energy Levels, Appetite, Mood, metabolism, Blood glucose, Body weight management, Waist circumference, Hip circumference, Leptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo （Microcrystalline Cellulose） |
| Dihydroberberine（DHB） | Experimental | Not described Receives: Dietary Supplement: Dihydroberberine（DHB） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Secondary outcomes (31)
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.
Measured: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Plasma Glucose Maximum Concentration (Cmax)
Maximum concentration (Cmax) of plasma glucose following a Mixed-meal Tolerance Test (MTT) after a single dose of study product.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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) .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion16 Aug 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health Adult SubjectsStudies 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
- 120 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322679
- Sponsor's protocol ID
- NNBHCS-BIO-2513
- Acronym
- DHB
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 7 Jan 2026
- 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 35010998Yang 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.
PubMed 22474499Zhang 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.
PubMed 19800084Chan 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.
PubMed 34931749
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dihydroberberine Supplementation on Body Composition, Glycemic Control, Energy Levels, Appetite, and Mood in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
- ClinicalTrials.gov ID
- NCT07322679
- Acronym / sponsor ID
- DHB / NNBHCS-BIO-2513
- Conditions
- Health Adult Subjects
- Keywords
- Glucovantage®, DHB, Dihydroberberine, Body Composition, Glycemic Control, Energy Levels, Appetite, Mood
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing Nutrabuilding Bio-tech Co., Ltd.University, hospital or other
- Collaborators
- Biofortis, Merieux NutriSciences
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 16 Aug 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 7 Jan 2026 (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 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
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 （Microcrystalline Cellulose） |
| Dihydroberberine（DHB） | Experimental | Dietary Supplement: Dihydroberberine（DHB） |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 35 - 55 years of age (inclusive) at visit 1.
- BMI ≥ 27.0 - ≤ 33.0 kg/m2.
- 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).
Key exclusion criteria (25 listed)
- Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
- Individuals undergoing moderate-to-intense activity (e.g., sports/exercise ≥ 5h/wk).
- Recent weight changes (>4.5 kg ≤ 90 d of visit 1), or current/planned engagement in a weight change program (e.g., weight loss or muscle gain) outside of the researcher-instructed, self-directed Lifestyle Intervention throughout the study period.
- Abnormal laboratory test results of clinical significance at visit 1, at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2, for subjects with abnormal laboratory test results.
- Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. Conditions that are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
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 （Microcrystalline Cellulose）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. | Dietary supplement | Placebo |
| Dihydroberberine（DHB）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. | Dietary supplement | Dihydroberberine（DHB） |
Primary outcome
Body weight
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
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).
31 secondary outcomes
Plasma Glucose Positive Incremental Area Under the Curve (piAUC)
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Plasma Glucose Maximum Concentration (Cmax)
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Plasma Glucose Time to Maximum Concentration (Tmax)
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Composite Appetite Score Net Incremental Area Under the Curve (niAUC)
Time frame: 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
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Composite Appetite Score Positive Maximum Response
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Individual Appetite Visual Analog Scale (VAS) Ratings Positive Maximum Response
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Energy Composite Score Net Incremental Area Under the Curve (niAUC)
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Energy Composite Score Positive Maximum Response
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Fatigue Composite Score Net Incremental Area Under the Curve (niAUC)
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Fatigue Composite Score Positive Maximum Response
Time frame: Baseline (Visit 2, Day 1): t=0 to t=120 minutes
Waist Circumference (WC)
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Hip Circumference (HC)
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Waist-to-Hip Ratio (WHR)
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Lean Mass
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Fat Mass
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Fat-Free Mass
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Visceral Adipose Tissue (VAT)
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Fasting Plasma Glucose
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Fasting Plasma Insulin
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Glycated Hemoglobin (HbA1c)
Time frame: 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)
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Fasting Plasma Leptin
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Postprandial Glucose niAUC (0-120 min)
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Postprandial Glucose Cmax
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
Postprandial Glucose Tmax
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)
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 Jan 2026.
- Background: 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.
- Background: PubMed 22474499Yang 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.
- Background: PubMed 19800084Zhang 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.
- Background: PubMed 34931749Chan 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.
- 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.
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） in people with Health Adult Subjects, 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 7 inclusion and 25 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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 Elizabeth Antoo, MD (630-617-2000, elizabeth.antoo@mxns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)). 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 NCT07322679, which also lists 4 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 Jan 2026.