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Berbevis® – Berberine Indena Phytosome™

Berbevis® – Berberine Indena Phytosome™

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Pharmacokinetics innovation1

A pharmacokinetic study has shown Berbevis® greatly favors berberine’s bioaccessibility profile (AUC) on molar basis and with observed dose linearity. The pharmacokinetic profile of total and free berberine after the administration of Berbevis®and of berberine chloride to healthy volunteers was tested in a study with twelve healthy volunteers of both sexes with a mean age of 29 ± 7.72 and a mean BMI of 23.09 ± 1.27.

 

Metabolic health2

A human randomized-controlled, double-blind, versus placebo trial with Berbevis® showed that a 60-day supplementation may help support the balance of blood sugar levels in individuals with challenged fasting glucose. Participants who took the ingredient experienced a favorable shift in fasting glycemia compared to those receiving the placebo.

Lipid values also followed a positive trend. Total cholesterol, triglycerides, and the cholesterol/HDL ratio moved in a more balanced direction in the supplemented group, suggesting a potential benefit for metabolic well-being.

Regarding insulin and glucose management, the data indicated a more favorable pattern in both insulin levels and the HOMA index—an important marker of insulin resistance.

Furthermore, the ApoB/ApoA ratio and total cholesterol values, showed a meaningful adjustment in the Berbevis® group: this shift may reflect a healthier lipid profile, which could contribute to maintain an overall lipid metabolism in shape.

In terms of body composition, participants receiving Berbevis® showed a tendency toward lower levels of: visceral fat, total fat mass and waist circumference.

The supplementation was well tolerated throughout the study, with no reported side effects.

Lipid metabolism health3

Berbevis® has already proven its effectiveness in modulating body composition and balancing the lipid profile.

Another study further validates that all its positive effects can be achieved with a single daily 550-mg dose.

Specifically, the study administered, for 90 days, Berbevis® to two different populations: subjects with stable hyperlipidemia (n=47; Standard Management + Berbevis® vs Standard Management) and with occasional hyperlipidemia (n=25; Standard Management + Berbevis® vs baseline).

In both cases, Berbevis® showed a positive influence on body composition and lipid profile (see Figures 1 and 2).

STABLY HYPERLIPIDEMIC SUBJECTS

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Figure 1: Effects of a single daily dose of Berbevis® in stably hyperlipidemic subjects, considering HDL, total cholesterol, TG and body composition (weight and fat/muscle ratio).

OCCASIONALLY HYPERLIPIDEMIC SUBJECTS

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Figure 2: Effects of a single daily dose of Berbevis® in occasionally hyperlipidemic subjects, considering HDL, total cholesterol, TG and body composition (weight and fat/muscle ratio).

Hormonal health4

Polycystic Ovary Syndrome (PCOS) is a common multifactorial condition that affects hormone functions in women of reproductive age. It can involve irregular cycles, acne, changes in weight and fat distribution, and challenges related to metabolism. These physical aspects often have emotional and social consequences, influencing overall quality of life.
 
In a study involving 12 women (average age 26.6 years; BMI 25.3) with PCOS and regular cycles, Berbevis® was supplemented for 60 days. 
 
Berbevis® significantly optimized insulin, blood glucose and lipid profiles.
 
Markers associated with androgen levels showed favorable changes which led to a more stable hormonal profile, help alleviating common symptoms such as acne and oily skin.
 
Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI) scores optimization reflected not just external appearance, but also mood, self-confidence and thus the overall quality of life. 
 
Finally, indicators linked to chronic inflammation (like CRP and TNF-α)  shifted in a direction associated with better balance.
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Figure 3. Descriptive statistics for the body composition measured at baseline (t0) and after 60 days (t2) of Berbevis® supplementation.W/H: Waist/Hip Ratio; BMI: Body Mass Index. *p<0.05; **p<0.005.

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Figure 4. Effectiveness on body composition, inducing a redistribution of adipose tissue with the reduction of the visceral fat tissue and fat mass. *p<0.005.

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Figure 5. Effect of Berbevis® on HOMA index in PCOS individuals (*p≤0.005).

Berbevis® significantly improves blood sugar profile optimizing both glucose and insulin (Figure 6)2.

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Figure 6. Effect of Berbevis® on the glycemic profile in PCOS individuals (*p≤0.005; **p<0.0005).

BIBLIOGRAPHY
1Petrangolini G. et al.; Evid Based Complement Alternat Med. Nov (2021) 
2Rondanelli M. et al.; Eur Rev Med Pharmacol Sci. Jul;27(14):6718-6727 (2023).
3Cesarone MR. et al.; Minerva Gastroenterol (Torino).70(1):10-15. (2024).

4Rondanelli M. et al.; Nutrients. Oct 19;13(10):3665 (2021). 

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