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

Trial Summary

What is the purpose of this trial?

This randomized, triple-blind, placebo-controlled study will evaluate the efficacy of Diaberine, a berberine-based nutraceutical, in aiding blood sugar regulation and metabolism in 80 participants over 24 weeks.

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.

What evidence supports the effectiveness of the drug Diaberine for diabetes?

Research shows that berberine, a key component of Diaberine, can help lower blood sugar and cholesterol levels, improve insulin resistance, and support better metabolism in diabetes. It has been used in traditional medicine for its beneficial effects on blood sugar control and has shown promise in managing diabetes-related metabolic disorders. ^{1 2 3 4 5}

Is Diaberine (Berberine) safe for humans?

Berberine is generally safe for humans at low doses, but higher doses can cause stomach issues like diarrhea. It is often used for diabetes and gut discomfort, and it may help prevent certain side effects of diabetes medications. ^{2 4 6 7 8}

How is the drug Diaberine different from other diabetes treatments?

Diaberine, which contains berberine, is unique because it not only helps lower blood sugar and cholesterol but also has an anti-diarrheal effect, making it suitable for diabetic patients with gut discomfort. Additionally, it has been shown to improve insulin resistance and pancreatic beta cell function, offering a multifaceted approach to managing diabetes. ^{1 2 3 4 9}

Eligibility Criteria

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

Be generally healthy

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.

I have not taken specific prescription medications in the last 2 months.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The role of a fixed Berberis aristata/Silybum marianum combination in the treatment of type 1 diabetes mellitus. [2023]

2. Italy 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. [2022]

3. China 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]. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Absorption Kinetics of Berberine and Dihydroberberine and Their Impact on Glycemia: A Randomized, Controlled, Crossover Pilot Trial. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Nano strategies for berberine delivery, a natural alkaloid of Berberis. [2018]

6. Iran pubmed.ncbi.nlm.nih.gov

Berberine protects against metformin-associated lactic acidosis in induced diabetes mellitus. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Antidiabetic properties of berberine: from cellular pharmacology to clinical effects. [2022]

8. England pubmed.ncbi.nlm.nih.gov

8,8-Dimethyldihydroberberine with improved bioavailability and oral efficacy on obese and diabetic mouse models. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Berberine improves neurogenic contractile response of bladder detrusor muscle in streptozotocin-induced diabetic rats. [2015]