Diaberine Supplement for Diabetes

Overseen By Patrick Renner, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ultimate International, Inc.

Must not be taking: Diabetes meds, Beta-blockers, Corticosteroids, others

Disqualifiers: Type 2 diabetes, Pregnancy, Chronic conditions, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supplement called Diaberine to determine its effectiveness in regulating blood sugar and improving metabolism. The study compares Diaberine to a placebo (a pill with no active ingredients) to assess its true effect. It seeks participants who are generally healthy, have a BMI of 27-35, and an HbA1c (a measure of blood sugar over time) between 5.7% and 6.4%. Participants should not use any medications or supplements that affect blood sugar or metabolism and must be willing to maintain their current lifestyle during the study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on a potentially beneficial supplement.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any products, prescription medications, or supplements that target blood sugar regulation or metabolism during the trial.

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

Research shows that berberine, a key component of Diaberine, is generally safe for individuals with type 2 diabetes. Studies have found that it can help lower blood sugar levels. Monitoring blood sugar closely is important, as berberine might cause it to drop too low when combined with diabetes medications. Berberine is affordable and considered a good option to try before starting insulin. Although the U.S. Food and Drug Administration does not evaluate berberine for safety, existing studies suggest it is well-tolerated. Consulting a healthcare provider before starting any new supplements is always advised. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard diabetes treatments, which often focus on insulin management or blood sugar stabilization through medications like metformin, Diaberine is unique because it combines natural ingredients such as berberine, Vitamin B12, and water-extracted cinnamon bark. These components are known for their potential to enhance insulin sensitivity and support metabolic health in a more holistic way. Researchers are particularly excited about the inclusion of berberine, which has been shown to mimic some effects of insulin, potentially offering a novel mechanism of action. Additionally, the use of cinnamon bark may provide antioxidant benefits, which could help reduce inflammation associated with diabetes.

What evidence suggests that Diaberine might be an effective treatment for diabetes?

Studies have shown that berberine, a key ingredient in Diaberine, effectively manages type 2 diabetes. Research indicates it lowers blood sugar levels and improves fat processing in the body. It also enhances insulin sensitivity, helping the body use insulin more effectively. Some studies found that berberine significantly improves metabolic syndrome issues, including blood sugar and cholesterol levels. While reports mention mild side effects like nausea, the overall evidence supports its potential for improving diabetes management. Participants in this trial will receive either the Diaberine supplement or a placebo to further evaluate its effectiveness. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with metabolic disorders or diabetes who are interested in trying a berberine-based supplement, Diaberine, to help control blood sugar and metabolism. Specific eligibility details were not provided.

Inclusion Criteria

HbA1c of 5.7%-6.4% (determined by prescreening blood test)

Willing to maintain their current diet, sleep schedule, and activity level for the duration of the study

BMI: 27-35 kg/m2

Exclusion Criteria

I have Type 2 diabetes and am on medication for it.

I have not had a major illness in the last three months.

Anyone unwilling or unable to follow the study protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Diaberine or placebo for blood sugar regulation and metabolism over 24 weeks

24 weeks

Visits at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diaberine

Trial Overview

The study tests the effectiveness of Diaberine against a placebo over 24 weeks. It's randomized (participants are put into groups by chance), triple-blind (neither researchers nor participants know who gets what treatment), and placebo-controlled.

How Is the Trial Designed?

Group I: Diaberine Experimental Treatment 1 Intervention

Participants in this arm will receive the Diaberine supplement, which contains Vitamin B12, berberine, magnesium citrate, water-extracted cinnamon bark (Cinnamomum cassia) at a 10:1 ratio, chromium (picolinate), rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).

Group II: Placebo Placebo Group 1 Intervention

Participants in this arm will receive a placebo capsule containing rice flour, dicalcium phosphate, l-leucine, and HPMC (capsule).

Diaberine is already approved in China, United States for the following indications:

Approved in China as Berberine for:

• Type 2 diabetes
• Blood sugar regulation

Approved in United States as Berberine for:

• Dietary supplement for blood sugar regulation and metabolism (not FDA-approved for prescription use)

Who Is Running the Clinical Trial?

Ultimate International, Inc.

Lead Sponsor

Trials

1

Recruited

80+

Citruslabs

Industry Sponsor

Trials

94

Recruited

5,100+

Published Research Related to This Trial

Berberine enhances glucose metabolism by increasing insulin secretion and activating the AMPK pathway, which helps lower insulin resistance and promotes glucose uptake in tissues like muscle and liver.

Clinical trials indicate that berberine is effective as an antidiabetic agent with good tolerability at low doses, although higher doses may cause gastrointestinal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic properties of berberine: from cellular pharmacology to clinical effects. Cicero, AF., Tartagni, E.[2022]

Berberine, derived from traditional Chinese herbs, has been used as an antibacterial treatment for gastrointestinal issues and is now recognized for its potential benefits in managing diabetes-related metabolic disorders.

The mechanisms by which berberine aids in diabetes management include lowering blood glucose levels, improving insulin sensitivity, regulating cholesterol and triglyceride levels, and enhancing pancreatic beta cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advances of the mechanism study on berberine in the control of blood glucose and lipid as well as metabolism disorders]. Shen, N., Li, CN., Huan, Y., et al.[2021]

In a study involving 75 male Wistar rats with induced diabetes, berberine was found to significantly reduce the occurrence of metformin-associated lactic acidosis (MALA), indicating its potential protective effect.

Berberine treatment also improved insulin resistance and liver enzyme levels in the rats, suggesting additional metabolic benefits beyond just preventing MALA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Berberine protects against metformin-associated lactic acidosis in induced diabetes mellitus. Almani, SA., Memon, IA., Shaikh, TZ., et al.[2022]

Berberine, a natural compound from certain Chinese herbs, has multiple therapeutic effects, particularly in improving glucose and lipid metabolism in type 2 diabetes through mechanisms like activating AMPK and stimulating glycolysis.

Despite its benefits, berberine's poor solubility and low bioavailability limit its use, but nanotechnology offers promising solutions by using various nanocarriers to enhance its delivery and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nano strategies for berberine delivery, a natural alkaloid of Berberis. Mirhadi, E., Rezaee, M., Malaekeh-Nikouei, B.[2018]

Dihydroberberine (D100 and D200) significantly increased plasma concentrations of berberine compared to a 500 mg dose of traditional berberine (B500) and placebo, suggesting better bioavailability of dihydroberberine.

No significant changes in glucose and insulin levels were observed in the study, indicating that further research is needed to evaluate the long-term effects of berberine and dihydroberberine on glucose metabolism in populations with glucose intolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absorption Kinetics of Berberine and Dihydroberberine and Their Impact on Glycemia: A Randomized, Controlled, Crossover Pilot Trial. Moon, JM., Ratliff, KM., Hagele, AM., et al.[2022]

Dihydroberberine analog 8,8-dimethyldihydroberberine (Di-Me) shows improved stability and bioavailability compared to dihydroberberine, making it a more effective option for treating type 2 diabetes.

In studies with diet-induced obese mice and db/db mice, Di-Me significantly reduced blood glucose levels, improved glucose tolerance, and alleviated insulin resistance, demonstrating better efficacy than dihydroberberine at similar dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

8,8-Dimethyldihydroberberine with improved bioavailability and oral efficacy on obese and diabetic mouse models. Cheng, Z., Chen, AF., Wu, F., et al.[2022]

In diabetic rats, the ability of the detrusor muscle in the urinary bladder to contract in response to nerve stimulation is significantly reduced, while the response to purinergic stimulation is increased, indicating altered muscle function due to diabetes.

Berberine, a compound from Coptidis Rhizoma, enhances the contractile response of the detrusor muscle to nerve stimulation, particularly in diabetic rats, by increasing the release of acetylcholine, suggesting its potential as a therapeutic agent for bladder dysfunction in diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Berberine improves neurogenic contractile response of bladder detrusor muscle in streptozotocin-induced diabetic rats. Ren, LM., Zhuo, YJ., Hao, ZS., et al.[2015]

In a study of 59 diabetic patients with dyslipidemia, the food supplement Berberol®K (BSM) significantly reduced glycated hemoglobin (HbA1c) by approximately 5% and cholesterol levels (total cholesterol by 23%, LDL by 31%, and triglycerides by 20%) after 6 months of treatment.

BSM was found to be safe, with no significant changes in liver enzymes or muscle damage markers, and it notably reduced diarrhea incidence, with only 5 out of 31 treated patients experiencing diarrhea compared to 22 out of 28 untreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in diabetic patients with dyslipidemia. Di Pierro, F., Putignano, P., Villanova, N.[2022]

In a study involving 85 type 1 diabetes patients over six months, the addition of Berberis aristata/Silybum marianum (Berberol) resulted in a significant reduction in total insulin consumption compared to both baseline and placebo.

Patients taking Berberol also showed improvements in glycemic control, with decreases in fasting plasma glucose and post-prandial glucose levels, as well as favorable changes in lipid profiles, including lower total cholesterol and triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of a fixed Berberis aristata/Silybum marianum combination in the treatment of type 1 diabetes mellitus. Derosa, G., D'Angelo, A., Maffioli, P.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

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

Efficacy of Berberine in Patients with Type 2 Diabetes - PMC

This pilot study indicates that berberine is a potent oral hypoglycemic agent with beneficial effects on lipid metabolism.

2.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2830825

A Berberine Derivative for Treatment of Type 2 Diabetes

Only 1 patient reported nausea, and another reported diarrhea, both at the lower dose. One retinal hemorrhage occurred in the intervention group ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12016319/

Berberine and health outcomes: an overview of systematic ...

Berberine significantly improves type 2 diabetes, gastrointestinal disorders, schizophrenia, metabolic syndrome, and dyslipidemia outcomes.

4.

frontiersin.org

frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1572197/full

Efficacy and safety of berberine on the components ...

Conclusion: Berberine significantly improves glucose and lipid metabolism and has notable effects on components of MetS, including TG, FPG, and ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2589936825000556

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

Berberine (BBR) exhibits significant anti-diabetic effects by enhancing insulin sensitivity, promoting glycolysis, and inhibiting gluconeogenesis.

6.

webmd.com

webmd.com/vitamins/ai/ingredientmono-1126/berberine

Berberine – Uses, Side Effects, and More

Taking berberine along with diabetes medications might cause blood sugar to drop too low. Monitor your blood sugar closely.

7.

health.clevelandclinic.org

health.clevelandclinic.org/berberine

Berberine: What It Is, Benefits & Side Effects

And like all supplements, the U.S. Food and Drug Administration (FDA) doesn't regulate berberine for safety and effectiveness. ... safety data is ...

8.

nebraskamed.com

nebraskamed.com/diabetes/is-berberine-a-safe-alternative-treatment-for-diabetes

Is berberine a safe alternative treatment for diabetes?

The research has concluded that berberine is a good treatment option to try before insulin therapy and may offer better results than metformin.

9.

uclahealth.org

uclahealth.org/news/article/what-know-about-berberine-so-called-natures-ozempic

What to know about berberine, the so-called "nature's ...

Studies show that berberine significantly lowers triglycerides — high levels are associated with obesity, metabolic syndrome and Type 2 diabetes ...