Dihydroberberine for Healthy Adults

(DHB Trial)

Overseen By Elizabeth Antoo, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

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

Must not be taking: Anti-hyperglycemics, Weight loss drugs

Disqualifiers: Diabetes, Hypertension, Cancer, others

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dihydroberberine (DHB) supplements can improve body weight, blood sugar control, energy, appetite, and mood in adults who are overweight or have mild obesity. Participants will take either DHB or a placebo for 12 weeks to observe any positive changes. It suits adults aged 35-55 with a BMI between 27.0 and 33.0 kg/m² who do not regularly use tobacco or marijuana. The study requires attending a few clinic visits and completing some tests and questionnaires. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of DHB supplements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have any recent changes in prescription medications within 90 days before starting the trial. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that dihydroberberine is likely to be safe for humans?

Studies have shown that converting berberine into dihydroberberine (DHB) makes it safer and gentler on the stomach. While berberine can sometimes cause stomach problems, DHB is designed to reduce these issues. Research indicates that DHB is absorbed better by the body than regular berberine, potentially making it easier to tolerate.

A study on berberine, from which DHB is derived, found it generally safe for long-term use, with only mild stomach issues reported. This suggests that DHB, as an improved version, could be even gentler on the stomach.

In summary, the safety profile for DHB appears favorable, and it seems well-tolerated based on current research. However, for specific concerns, discussing them with the trial team or a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dihydroberberine is unique because it is a derivative of berberine, which has been used traditionally for various health benefits, especially in managing blood sugar levels. Unlike standard treatments for blood sugar management, which often include drugs like metformin, dihydroberberine boasts higher bioavailability, meaning it is absorbed more effectively by the body. Researchers are excited about dihydroberberine because this improved absorption could lead to better and more consistent results, potentially with fewer side effects. Additionally, its natural origin as a derivative of berberine may appeal to those looking for more naturally derived treatment options.

What evidence suggests that dihydroberberine might be an effective treatment for improving body composition and blood sugar control in healthy adults with overweight or mild obesity?

Research suggests that dihydroberberine (DHB), which participants in this trial may receive, might help improve body shape and control blood sugar levels. Studies have shown that DHB reaches higher levels in the blood than berberine, potentially leading to better health outcomes. The body absorbs DHB more easily. Previous research on berberine, a similar substance, showed it could significantly lower blood sugar and improve blood health markers like HbA1c. These findings indicate that DHB might assist with weight loss and blood sugar management in healthy adults who are overweight or mildly obese. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 35-55 with a BMI of 27.0 to 33.0, who don't use tobacco or marijuana regularly and are willing to follow study procedures and use a smartphone app. They must have good vein access for blood draws.

Inclusion Criteria

I agree to follow the study rules and sign consent forms.

My BMI is between 27.0 and 33.0.

My vein access score is between 7 and 10.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive DHB or placebo for 12 weeks, with assessments including MTTs, body composition, and mood questionnaires

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dihydroberberine

Trial Overview

The trial tests if dihydroberberine (DHB) can improve body composition, blood sugar control, energy levels, appetite, and mood in overweight individuals compared to a placebo over 12 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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07322679

Dihydroberberine Effects on Body Composition and ...

The goal of this clinical trial is to evaluate whether dihydroberberine (DHB) supplementation can improve body composition, blood sugar control, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8746601/

Absorption Kinetics of Berberine and Dihydroberberine and ...

Results from this study demonstrate that dihydroberberine, irrespective of what dose is delivered, achieves greater area under the curve as well ...

3.

gethealthspan.com

gethealthspan.com/research/article/dihydroberberine-metabolic-regulation-cellular-senescence-reduction?srsltid=AfmBOooSDRpKmxv6o84g-QbRqdrmbw3jXb03okU-Wok_bxdhR4KE2on5

Dihydroberberine: A Promising Agent in Metabolic Regulation ...

Multiple studies have demonstrated the superiority of DHB over Berberine in terms of bioavailability and subsequent health outcomes.

4.

faynutrition.com

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

Dihydroberberine vs. berberine for Diabetes

Both 100mg and 200mg doses of dihydroberberine produced significantly higher blood levels of berberine than a 500mg dose of berberine itself ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589936825000556

Berberine's impact on health: Comprehensive biological ...

Zhang et al. reported that a daily intake of 1 g of BBR resulted in a 20 % reduction in blood glucose, a 12 % decrease in HbA1c, and an improvement in lipid ...

6.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0194979

Comparative pharmacokinetics and safety assessment of ...

This study supports the safe use of transdermal compositions that improve on the poor bioavailability of oral berberine and have the potential to be more ...

7.

gethealthspan.com

gethealthspan.com/research/article/dihydroberberine-metabolic-regulation-cellular-senescence-reduction?srsltid=AfmBOopRifx61jy28ORh0wmdlnmFXlCf6pF5a1sexh7qV03luj69MOL0

Dihydroberberine: A Promising Agent in Metabolic Regulation ...

Furthermore, transforming Berberine into DHB also makes the compound safer and more tolerable for individuals. Berberine, in its original form, ...

8.

mdpi.com

mdpi.com/2218-1989/15/4/240

A 30-Day Randomized Crossover Human Study on the ...

While both short- and long-term uses of berberine are generally regarded as safe, with only a few side effects reported—primarily related to digestive issues, ...