What is Dihydroberberine (DHB) studying for pre-diabetes?

Dihydroberberine (DHB) is being studied to see if it affects levels of GLP-1, a hormone that helps control blood sugar, as well as appetite, mood, energy, body weight, and insulin in adults with pre-diabetes. This research aims to understand if DHB supplementation can influence these factors compared to a placebo. The study is sponsored by Nanjing Nutrabuilding Bio-tech Co., Ltd.

Who may be eligible for this pre-diabetes clinical trial?

Adults aged 35 to 65 years with a body mass index between 25.0 and 35.0, and an HbA1c level between 5.7% and 6.4% may be eligible. Both men and women can participate. Participants should not be recent or current daily tobacco users and must be willing to wear a continuous glucose monitor and use smartphone apps. Please review eligibility criteria for more details.

Is there any cost to participate in this pre-diabetes clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 35Years - 65Years

All Genders

ID07210684

Study of Dihydroberberine DHB Effects on Blood Sugar, Appetite, and Mood in Adults With Prediabetes Ages 35 to 65

Led by Nanjing Nutrabuilding Bio-tech Co., Ltd. · Updated on 2025-10-07

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Dihydroberberine DHB supplementation in adults with pre-diabetes. The study aims to find out if DHB increases the blood levels of GLP-1, a hormone involved in blood sugar control, and how it affects appetite, mood, energy, body weight, blood sugar, and insulin. Participants will be compared to a placebo group to see if DHB has any measurable impact. Participants will take either DHB or a placebo daily for 6 weeks. The DHB group will receive four 100 mg capsules each day, totaling 400 mg daily, while the placebo group will receive four capsules containing an inactive substance. The study includes several visits during which blood and other markers related to GLP-1, glucose, and insulin will be tested after a single dose and after 6 weeks of supplementation. During the study, participants will wear continuous glucose monitors CGMs to track blood sugar levels and spend time in healthy glucose ranges. They will also rate their appetite, mood, and energy using visual scales. Researchers will assess changes in GLP-1 levels, blood sugar control, insulin resistance, and subjective feelings related to appetite and mood. The total study duration for each participant is about 6 weeks, with various laboratory tests, glucose monitoring, and questionnaires completed during this time.

CONDITIONS

Brief Title

Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes

Who Can Participate

Age: 35Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 35 and 65 years (inclusive)
Body mass index (BMI) between 25.0 and 35.0 kg/m2 (inclusive)
HbA1c level between 5.7% and 6.4% measured at first visit
Vein Access Scale score between 7 and 10 at first visit
Non-user or former daily user of tobacco or nicotine products for at least 12 months
Non-habitual user of marijuana or hemp products and willing to abstain during study (topical allowed)
Willing to wear a continuous glucose monitor (CGM) during the study
Willing to use a smartphone capable of running required apps for diet and glucose monitoring
Willing to follow all study procedures and provide informed consent

You will not qualify if you...

Following extreme diets (e.g., ketogenic, vegan/vegetarian) as determined by investigator
Engaging in moderate-to-intense exercise 5 or more hours per week
Recent weight changes greater than 4.5 kg in past 90 days or current/planned weight change program
Abnormal lab test results of clinical significance at first visit (one retest allowed)
Uncontrolled or clinically important chronic illnesses including pulmonary, cardiac, hepatic, renal, endocrine (excluding type 1 and 2 diabetes), hematologic, immunologic, neurologic, psychiatric, or biliary disorders
Clinically significant gastrointestinal conditions affecting study product use (e.g., inflammatory bowel disease, celiac disease, history of weight loss surgery)
Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg)
History or presence of cancer in past 2 years (except non-melanoma skin cancer)
Signs or symptoms of active infection within 5 days of first visit
Recent use (within 6 months) of prescription anti-hyperglycemic medications
Use of dietary supplements other than approved multivitamins within 14 days of first visit
History of alcohol abuse (>14 drinks/week) or substance abuse within 12 months
Antibiotic use within 90 days of first visit
Regular use of anti-inflammatory medications 3 or more days per week within 30 days
Recent use of oral, injectable, or high-dose topical/inhaled steroids within 30 days
Exposure to any non-registered drug product within 30 days of first visit
Unstable doses of other prescription medications within 90 days
Psychiatric hospitalization within 12 months prior to first visit
Major trauma or surgery within 30 days
Endoscopy or colonoscopy preparation within 90 days
Planned elective surgical procedures during study
Pregnancy, lactation, planning pregnancy, or unwillingness to use contraception
Known allergies to study products or foods
Any condition interfering with compliance, confounding results, or presenting undue risk as judged by investigator

Research Team

Kotryna Dzekcioriute

Elizabeth Antoo, MD

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Study of Dihydroberberine DHB Effects on Blood Sugar, Appetite, and Mood in Adults With Prediabetes Ages 35 to 65

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria