New supplement trial aims to boost weight loss and energy in overweight adults
NCT ID NCT07322679
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether taking dihydroberberine (DHB) daily for 12 weeks can improve body weight, blood sugar control, energy, appetite, and mood in healthy adults aged 35-55 who are overweight or mildly obese. Participants will be randomly assigned to receive DHB or a placebo, and will undergo tests including body scans and meal challenges. The goal is to see if DHB offers any benefits beyond a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dihydroberberine (DHB)
- What this could lead to
- If it works, this could point toward a natural supplement for managing weight and improving energy and mood in people with mild obesity.
- What could go wrong
- This is an early-stage trial with only 120 participants, so results may not apply to everyone. The supplement may show no benefit over placebo, and long-term safety is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Biofortis, Merieux NutriSciences
Addison, Illinois, 60101, United States
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