Not Yet RecruitingNot Applicable

Dihydroberberine Effects on Body Composition and Metabolic Health in Healthy Adults

United States120 participantsStarted 2025-12-15

Plain-language 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

Who can participate

Age range

35 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Body weight

Timeframe: Baseline (Visit 2, Week 0, Day 1) to End of the Study (Visit 3, Week 12, Day 84)

Trial details

NCT IDNCT07322679

SponsorNanjing Nutrabuilding Bio-tech Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-16

Contact for this trial

Elizabeth Antoo, MD

630-617-2000 elizabeth.antoo@mxns.com

View on ClinicalTrials.gov More Health Adult Subjects trials