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
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.
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.
Parallel
Placebo （Microcrystalline Cellulose）
Dietary supplementParticipants 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 supplementParticipants 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.
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).
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.
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.
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.
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.
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.
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.
Blood Pressure
Change in resting systolic blood pressure and diastolic blood pressure from Baseline to the End of the Study.
Heart Rate
Change in resting heart rate from Baseline to the End of the Study.
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Nanjing Nutrabuilding Bio-tech Co., Ltd.
Lead sponsor
Biofortis, Merieux NutriSciences
Collaborator
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