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Clinical Trials/NCT07322679
NCT07322679
Not yet recruiting
Not Applicable

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

Nanjing Nutrabuilding Bio-tech Co., Ltd.1 site in 1 country120 target enrollmentStarted: December 15, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Enrollment
120
Locations
1
Primary Endpoint
Body weight
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
35 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •35 - 55 years of age (inclusive) at visit
  • •BMI ≥ 27.0 - ≤ 33.0 kg/m
  • •Participant has a score of 7 - 10 on the Vein Access Scale Assessment at visit
  • •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.

Exclusion Criteria

  • •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).
  • •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
  • •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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Plasma Glucose Positive Incremental Area Under the Curve (piAUC)(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Plasma Glucose Maximum Concentration (Cmax)(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Plasma Glucose Time to Maximum Concentration (Tmax)(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Composite Appetite Score Net Incremental Area Under the Curve (niAUC)(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(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Composite Appetite Score Positive Maximum Response(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Individual Appetite Visual Analog Scale (VAS) Ratings Positive Maximum Response(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Energy Composite Score Net Incremental Area Under the Curve (niAUC)(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Energy Composite Score Positive Maximum Response(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Fatigue Composite Score Net Incremental Area Under the Curve (niAUC)(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Fatigue Composite Score Positive Maximum Response(Baseline (Visit 2, Day 1): t=0 to t=120 minutes)
  • Waist Circumference (WC)(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Hip Circumference (HC)(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Waist-to-Hip Ratio (WHR)(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Lean Mass(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Fat Mass(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Fat-Free Mass(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Visceral Adipose Tissue (VAT)(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Fasting Plasma Glucose(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Fasting Plasma Insulin(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Glycated Hemoglobin (HbA1c)(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)(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Fasting Plasma Leptin(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Postprandial Glucose niAUC (0-120 min)(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Postprandial Glucose Cmax(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))
  • Postprandial Glucose Tmax(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)(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(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)(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(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(Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84))

Investigators

Sponsor
Nanjing Nutrabuilding Bio-tech Co., Ltd.
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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