Dihydroberberine for Prediabetes

(DHB Trial)

Overseen By Kotryna Dzekcioriute

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nanjing Nutrabuilding Bio-tech Co., Ltd.

Must not be taking: Anti-hyperglycemics, Antibiotics, Steroids, NSAIDs

Disqualifiers: Uncontrolled illness, Cancer, Extreme diets, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a supplement called Dihydroberberine (DHB) can aid individuals with prediabetes. Researchers aim to determine if DHB can boost GLP-1 levels in the blood, potentially affecting appetite, mood, energy, body weight, and blood sugar control. Participants will take either DHB or a placebo daily for six weeks to observe any changes. This trial may suit individuals with prediabetes who do not use nicotine products and are comfortable wearing a continuous glucose monitor (CGM) during the study. As an unphased trial, it offers a unique opportunity to contribute to early research on DHB's potential benefits for prediabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you've used anti-hyperglycemic medications in the last 6 months or certain other medications recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Dihydroberberine (DHB) is likely to be safe for humans?

Research has shown that dihydroberberine (DHB) is generally safe for people. Studies comparing DHB to berberine suggest that DHB causes fewer stomach problems because it can be taken in smaller amounts. Safety tests on DHB found no major concerns, indicating it is safe for humans. Berberine, similar to DHB, has been used in other treatments to help control blood sugar levels, supporting its safety. However, everyone may react differently, so side effects can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for prediabetes focus on lifestyle changes and medications like metformin to improve insulin sensitivity and glucose control. However, dihydroberberine (DHB) is unique because it is derived from berberine, a natural compound with potential metabolic benefits. DHB is believed to be more bioavailable than regular berberine, meaning it could be better absorbed by the body, potentially leading to more effective results. Researchers are excited about DHB because it may offer a novel way to manage blood sugar levels with fewer side effects and improved patient compliance compared to existing treatments.

What evidence suggests that Dihydroberberine might be an effective treatment for prediabetes?

This trial will compare Dihydroberberine (DHB) with a placebo to evaluate its effectiveness in managing prediabetes. Research shows that DHB might help manage this condition. In earlier studies, berberine, which is similar to DHB, significantly lowered blood sugar levels and improved sugar metabolism in people with prediabetes. Another study found that berberine reduced fasting insulin levels and enhanced insulin effectiveness. These findings suggest that DHB might help control blood sugar and improve overall health in people with prediabetes. ^{1 2 5 6 7}

Who Is on the Research Team?

Elizabeth Antoo, MD

Principal Investigator

Biofortis, Inc. Merieux NutriSciences

Are You a Good Fit for This Trial?

This trial is for adults with pre-diabetes, possibly including those with polycystic ovary syndrome. Participants should be interested in testing if a supplement can help control blood sugar and affect appetite or mood.

Inclusion Criteria

Willing to adhere to all study procedures and provide informed consent

Vein Access Scale Assessment score of 7 to 10 at visit 1

I haven't used tobacco or nicotine in the last year and don't plan to during the study.

Exclusion Criteria

History of alcohol or substance abuse within the last 12 months

Endoscopy or colonoscopy preparation within 90 days prior to Visit 1

I have recently used steroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take DHB or a placebo every day for 6 weeks and participate in tests to measure GLP-1 levels, blood glucose, insulin, and other markers.

6 weeks

Multiple visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in mood, appetite, and energy levels.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dihydroberberine (DHB)
• Placebo

Trial Overview The study tests Dihydroberberine (DHB) against a placebo to see its effects on GLP-1 levels, glycemic control, body weight, insulin levels, appetite, and mood over a period of 6 weeks.

How Is the Trial Designed?

Group I: Dihydroberberine（DHB） Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Nanjing Nutrabuilding Bio-tech Co., Ltd.

Lead Sponsor

Biofortis, Merieux NutriSciences

Industry Sponsor

Trials

9

Recruited

850+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37679692/

Efficacy and safety of HIMABERB® Berberine on glycemic ... After 12 weeks, berberine (HIMABERB®) intervention in individuals with prediabetes significantly reduced glycemic control markers.

2. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.70171?af=R

Dihydroberberine normalizes insulin secretion by regulating ... Berberine has been shown to protect against diabetes and lower plasma glucose in experimental animals and clinical patients as effectively as ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07210684

Effects of Dihydroberberine (DHB) on GLP-1, Glycemic ... The goal of this clinical trial is to learn if Dihydroberberine (DHB) supplementation affects adults with pre-diabetes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2410097/

Efficacy of Berberine in Patients with Type 2 Diabetes - PMC Fasting plasma insulin and HOMA-IR were reduced by 28.1% and 44.7% (P<0.001), respectively. Total cholesterol and low-density lipoprotein cholesterol (LDL-C) ...

5. bmcendocrdisord.biomedcentral.com bmcendocrdisord.biomedcentral.com/articles/10.1186/s12902-023-01442-y

Efficacy and safety of HIMABERB® Berberine on glycemic ... After 12 weeks, berberine (HIMABERB®) intervention in individuals with prediabetes significantly reduced glycemic control markers.

6. faynutrition.com faynutrition.com/post/dihydroberberine-vs-berberine-for-diabetes-what-research-shows

Dihydroberberine vs. berberine for Diabetes In theory, dihydroberberine should cause fewer digestive problems since you may be taking a lower dose compared to berberine HCL. However, with ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278691522004999

Toxicological assessment of dihydroberberine A battery of studies was conducted to examine the toxicological potential of dihydroberberine (DHBBR), a derivative of berberine (BBR).