Berbevis® - Clinical Research Data Summary
Berbevis® Berberine Phytosome
Berbevis® is a clinically studied ingredient used in the following Silver Fern™ Brand product:
- Metabolism – https://www.silverfernbrand.com/products/metabolism
Introduction
Berbevis® (berberine phytosome) is supported by multiple human clinical trials evaluating its role in metabolic, hormonal, and cardiometabolic health. Randomized, placebo-controlled studies in overweight individuals with elevated metabolic markers show that daily supplementation with Berbevis® supports healthy fasting glucose levels, insulin function, blood lipid balance, and body composition, while maintaining excellent tolerability at lower berberine doses. Additional clinical research in women experiencing hormonal imbalance has demonstrated improvements in metabolic markers, inflammatory status, and visible skin concerns. Preventive trials in individuals with elevated lipid markers further support Berbevis®'s ability to promote healthy cholesterol balance, support antioxidant defenses, and favorably influence body composition. Collectively, these studies highlight Berbevis® as a well-studied, bioavailable berberine formulation that supports healthy glucose metabolism, lipid balance, inflammatory response, and hormonal health.*
These are the studies for Berbevis®. Below, we provided a summary of each key data for each study, along with a link to the complete clinical research.
- Summary of Study 1 – Full Study: https://pubmed.ncbi.nlm.nih.gov/37522683/
- Summary of Study 2 – Full Study: https://pubmed.ncbi.nlm.nih.gov/34684666/
- Summary of Study 3 – Full Study: https://pubmed.ncbi.nlm.nih.gov/38074133/
- Summary of Study 4 – Full Study: https://www.minervamedica.it/en/journals/gastroenterology/article.php?cod=R08Y2024N01A0010
Ingredient Manufacturer Link: https://www.indena.com/us/product/berbevis/
Study 1 Summary
Complete Study Information: https://pubmed.ncbi.nlm.nih.gov/37522683/
Berberine Phospholipid Exerts a Positive Effect on the Glycemic Profile of Overweight Subjects with Impaired Fasting Blood Glucose (IFG): A Randomized Double-Blind Placebo-Controlled Clinical Trial
Rondanelli, M., et al. (2023).
Berberine Phytosome™ has been evaluated in a randomized, double-blind, placebo-controlled clinical trial examining its effects on metabolic markers and body composition in overweight adults with elevated fasting glucose levels. In this 60-day study involving 49 men and women, participants taking Berberine Phytosome™ (1,100 mg/day) demonstrated improvements in markers related to glucose metabolism, insulin function, lipid balance, and body composition compared to placebo. Participants also experienced reductions in visceral adipose tissue and total fat mass as measured by DXA, while maintaining lean mass. The ingredient was well tolerated throughout the study with no adverse effects reported.
Study Design Highlights
- Study design: Randomized, double-blind, placebo-controlled clinical trial
- Participants: 49 overweight adults with elevated fasting glucose levels
- Dose: 1,100 mg/day Berberine Phytosome™
- 2 tablets per day
- Each tablet: 550 mg Berbevis® (≈188 mg berberine per tablet)
- Duration: 60 days (8 weeks)
Key Findings (What the Study Showed)
1. Markers Related to Glucose Metabolism
- Fasting blood glucose: ↓ ~12%
- Insulin levels: ↓ ~28–30%
- HOMA-IR (marker associated with insulin function): improved
- HbA1c: downward trend observed
2. Lipid Markers
- Total cholesterol: ↓ ~10–15%
- Triglycerides: ↓ ~14%
- Total cholesterol / HDL ratio: improved
- ApoB / ApoA ratio: ↓ ~8%
3. Body Composition (DXA Measured)
- Visceral adipose tissue (VAT): ↓ ~9–10%
- Total fat mass: ↓ ~1 kg (~2.2 lb)
- Lean mass: maintained
4. Safety & Tolerability
- No adverse events reported
- Liver and kidney markers remained within normal ranges throughout the study
Benefits of Berbevis® Demonstrated by This Study
Based directly on the clinical outcomes, Berbevis® was shown to:
✓ Support healthy blood glucose metabolism
✓ Support healthy insulin function and HOMA-IR markers
✓ Support healthy cholesterol and triglyceride levels
✓ Support reductions in visceral adipose tissue
✓ Help maintain lean mass during body composition improvements
✓ Be well tolerated with no adverse effects at 1,100 mg/day
Why This Study Matters
Results from this clinical trial suggest that Berberine Phytosome™ (Berbevis®), taken at 1,100 mg per day for 60 days, supports healthy glucose metabolism, lipid balance, and body composition in overweight adults with elevated metabolic markers. These benefits were observed with excellent tolerability and at lower berberine doses than are typically used with conventional berberine supplements, highlighting the potential advantages of the phytosome delivery system.*
Reference Link: https://pubmed.ncbi.nlm.nih.gov/37522683/
Study 2 Summary
Complete Study Information: https://pubmed.ncbi.nlm.nih.gov/34684666/
Berberine Phytosome Is an Effective Insulin Sensitizer and Improves Metabolic and Hormonal Markers in Women with Polycystic Ovary Syndrome: A One-Group Pretest–Post-Test Explanatory Study
Rondanelli, M., et al. (2021). Nutrients, 13(10): 3665.
Berberine Phytosome™ has been evaluated in a human clinical study examining its effects on metabolic, hormonal, and body composition markers in women experiencing hormonal imbalance associated with elevated androgen levels. In this 60-day study, daily supplementation with a bioavailable berberine phytosome formulation was associated with improvements in markers related to insulin function, inflammatory balance, lipid metabolism, and body composition. Participants also experienced improvements in visible skin concerns and quality-of-life scores related to skin appearance. The ingredient was well tolerated, with no adverse changes observed in liver or kidney markers during the study period.
Study Design Highlights
- Study design: One-group pretest–post-test human clinical study
- Participants: 12 normal-to-overweight women experiencing hormonal imbalance associated with elevated androgen levels (mean age: ~27 years; mean BMI: ~25)
- Dose: 1,100 mg/day Berberine Phytosome™
- 2 tablets per day
- Each tablet: 550 mg bioavailable berberine phytosome
- Duration: 60 days (8 weeks)
- Safety monitoring: liver enzymes, kidney markers, and creatine phosphokinase (CPK)
Key Findings (What the Study Showed)
1. Markers Related to Metabolic Function
- HOMA-IR (marker associated with insulin function): ↓ ~42%
- Triglycerides: ↓ ~15–20%
2. Inflammatory Balance
- C-reactive protein (CRP): ↓ ~42%
- TNF-α: ↓ ~50%
3. Hormonal Markers
- Total testosterone: ↓ ~33%
- Free androgen index: ↓ ~25%
- Sex hormone–binding globulin (SHBG): increased
4. Body Composition (DXA Measured)
- Visceral adipose tissue (VAT): ↓ ~8–10%
- Total fat mass: ↓ ~1 kg (~2.2 lb)
- BMI: decreased during the study period
5. Skin Appearance & Quality of Life
- Acne severity scores (GAGS): improved
- Acne-related quality-of-life scores (CADI): improved
6. Safety
- No adverse changes observed in liver markers, kidney markers, or muscle enzyme markers (CPK)
- Good tolerability over the 60-day supplementation period
Benefits of Berbevis® Demonstrated by This Study
Based directly on the clinical outcomes, Berbevis® was shown to:
✓ Support healthy insulin function and HOMA-IR markers
✓ Support healthy triglyceride levels
✓ Help maintain healthy inflammatory balance (CRP and TNF-α)
✓ Support healthy androgen balance and SHBG levels
✓ Support reductions in visceral adipose tissue and total fat mass
✓ Support improvements in skin appearance and acne-related quality-of-life scores
✓ Be well tolerated with no adverse changes in liver, kidney, or muscle markers
Why This Study Matters
Results from this human study suggest that Berberine Phytosome™ (Berbevis®), taken at 1,100 mg per day for 60 days, supports healthy metabolic and hormonal balance, along with favorable changes in body composition and skin appearance markers in women experiencing hormonal imbalance. The ingredient demonstrated excellent tolerability while supporting several markers associated with metabolic wellness.*
Reference Link: https://pubmed.ncbi.nlm.nih.gov/34684666/
Study 3 Summary
Complete Study Information: https://pubmed.ncbi.nlm.nih.gov/38074133/
Effect of Berberine Phytosome on Reproductive, Dermatologic, and Metabolic Characteristics in Women with Polycystic Ovary Syndrome: A Controlled, Randomized, Multi-Centric, Open-Label Clinical Trial
Di Pierro, F., et al. (2023). Frontiers in Pharmacology, 14:1269605.
Berberine Phytosome® has been evaluated in a large multi-center human clinical study examining its effects on metabolic, hormonal, and dermatologic markers in women experiencing hormonal imbalance associated with elevated androgen levels. In this randomized, controlled, multi-center study involving 130 participants, supplementation with Berberine Phytosome® (1,100 mg/day) for 90 days was associated with improvements in menstrual cycle regularity, skin appearance markers, and indicators of hormonal balance compared to the control group. The ingredient was well tolerated throughout the study with no adverse effects reported.
Study Design Highlights
- Study design: Randomized, controlled, multi-center, open-label clinical trial
- Participants: 130 women experiencing hormonal imbalance associated with elevated androgen levels
- Dose: 1,100 mg/day Berberine Phytosome®
- 550 mg twice daily
- Duration: 90 days (3 months)
- Control group: Standard care without Berberine Phytosome®
- Clinical trial registration: NCT05480670
Key Findings (What the Study Showed)
1. Hormonal & Cycle-Related Markers
Participants taking Berberine Phytosome® showed improvements in menstrual cycle regularity compared to controls.
2. Dermatologic Markers
Participants demonstrated improvements in skin appearance markers, including reductions in acne severity and visible hair growth associated with androgen imbalance.
3. Metabolic Markers
Standard metabolic markers remained generally stable between groups, suggesting that the observed changes were related to hormonal and dermatologic markers rather than large shifts in metabolic laboratory values.
4. Safety
- Excellent tolerability throughout the study
- No adverse effects reported during the study period
Benefits of Berbevis® Demonstrated by This Study
Based directly on the clinical outcomes, Berbevis® was shown to:
✓ Support improvements in menstrual cycle regularity
✓ Support reductions in acne severity markers
✓ Support improvements in visible skin concerns associated with androgen imbalance
✓ Support healthy hormonal balance markers
✓ Be well tolerated across 130 participants in a multi-center setting
Why This Study Matters
Results from this multi-center clinical study suggest that Berberine Phytosome® (Berbevis®), taken at 1,100 mg per day for 90 days, supports hormonal balance and skin appearance markers associated with androgen levels in women experiencing hormonal imbalance. The ingredient demonstrated good tolerability and may provide nutritional support for hormonal and metabolic wellness when combined with healthy lifestyle habits.*
Reference Link: https://pubmed.ncbi.nlm.nih.gov/38074133/
Study 4 Summary
Complete Study Information: https://www.minervamedica.it/en/journals/gastroenterology/article.php?cod=R08Y2024N01A0010
Borderline Hyperlipidemia Preventive Management with Berberine PL in Asymptomatic Prevention of Early Atherosclerosis
Cesarone, M. R., et al. (2023). Minerva Gastroenterology, 69. DOI: 10.23736/S2724-5985.23.03540-4.
Berberine Phytosome® has been evaluated in a controlled human study examining its effects on lipid markers, body composition, and oxidative balance in adults with elevated lipid levels. Participants received Berberine Phytosome® alongside standard dietary and lifestyle recommendations and were assessed for changes in lipid markers, body composition, and markers related to oxidative balance. Supplementation with Berberine Phytosome® was associated with improvements in cholesterol and triglyceride markers, favorable changes in body composition, and improvements in oxidative balance markers. The ingredient was well tolerated throughout the study.
Study Design Highlights
- Study design: Controlled preventive human study
- Participants: Adults with elevated lipid markers
- Dose: 550 mg/day Berberine Phytosome®
- Duration: 3 months (90 days)
- Participants followed general diet and lifestyle guidance during the study period
Key Findings (What the Study Showed)
1. Lipid Markers
Participants taking Berberine Phytosome® demonstrated improvements in:
- Total cholesterol markers
- Triglyceride markers
- HDL cholesterol markers
Improvements were observed in individuals with both diet-related and genetically influenced lipid markers.
2. Body Composition
Participants also demonstrated favorable changes in:
- Body weight
- Body fat percentage
- Fat-to-muscle balance
3. Oxidative Balance
- Markers related to oxidative balance improved during supplementation
- CoQ10 status was maintained during the study
4. Safety
- No adverse effects reported
- High compliance among participants
Benefits of Berbevis® Demonstrated by This Study
Based directly on the clinical outcomes, Berbevis® was shown to:
✓ Support healthy total cholesterol and triglyceride levels already within the normal range
✓ Support healthy HDL cholesterol markers
✓ Support favorable body composition including body weight and fat-to-muscle balance
✓ Support healthy oxidative balance markers
✓ Maintain CoQ10 status during supplementation
✓ Be well tolerated with high compliance at 550 mg/day
Why This Study Matters
Results from this human study suggest that Berberine Phytosome® (Berbevis®), taken at 550 mg per day for 3 months, supports healthy lipid balance, body composition, and oxidative balance in adults with elevated lipid markers. The ingredient demonstrated excellent tolerability and may provide nutritional support for cardiometabolic wellness when combined with healthy lifestyle habits.*
Reference Link: https://www.minervamedica.it/en/journals/gastroenterology/article.php?cod=R08Y2024N01A0010
Big-Picture Integration with Other Studies
- Study 1: In a controlled human study, Berberine Phytosome™ (Berbevis®), taken at 1,100 mg/day for 60 days, was shown to support healthy glucose metabolism, insulin function, lipid balance, and favorable body composition in individuals with elevated metabolic markers.
- Study 2: In a 60-day human study of women experiencing hormonal imbalance, Berberine Phytosome® (1,100 mg/day) was associated with improvements in markers related to insulin sensitivity, inflammatory balance, androgen levels, body composition, and visible skin health, while demonstrating excellent tolerability.
- Study 3: In a randomized, multi-center clinical study of 130 women experiencing hormonal imbalance, Berberine Phytosome® (1,100 mg/day for 90 days) supported menstrual regularity, healthy ovarian function, and improvements in skin appearance, while being well tolerated.
- Study 4: In a 3-month human preventive study, Berberine Phytosome® (550 mg/day) supported healthy cholesterol and triglyceride levels, improved markers of oxidative balance, and promoted favorable body composition in individuals with elevated lipid markers.
Berbevis® Ingredient Summary & Real-World Relevance
Berbevis® (berberine phytosome) is a clinically studied, highly bioavailable form of berberine designed to support metabolic, hormonal, and cardiometabolic health. Human clinical studies demonstrate that Berbevis® supplementation can support healthy glucose metabolism, insulin function, lipid balance, and body composition in individuals with elevated metabolic markers, while maintaining excellent tolerability at lower berberine doses. Additional research in women experiencing hormonal imbalance has shown beneficial effects on metabolic markers, inflammatory balance, and visible skin concerns. Together, these findings highlight Berbevis® as a well-tolerated nutritional ingredient that supports healthy blood sugar balance, metabolic efficiency, lipid metabolism, and hormonal wellness—key factors that influence everyday wellbeing, including energy levels, body composition, and overall metabolic health.*
Ingredient Manufacturer Link: https://www.indena.com/us/product/berbevis/
Berbevis® is a clinically studied ingredient used in the following Silver Fern™ Brand product:
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.