The Efficacy and Safety of a Nutraceutical Combination Containing Bifidobacterium

The Risks of Cardiovascular Disease

Cardiovascular (CV) diseases related to atherosclerosis can cause disability, a worse outlook for other serious conditions, and death. In addition to people with severe hypercholesterolemia (high cholesterol), most with low or medium CV risk have moderate cholesterol levels that rise along with other biomarkers. This risk is often not diagnosed or treated correctly, which can be a big problem for people, especially when combined with unhealthy lifestyle habits.

What are Statins and their Side Effects on the Body?

Statins are prescribed drugs that can help lower cholesterol levels and reduce the risk of cardiovascular disease. However, statins can also cause side effects, such as muscle symptoms and diabetes, that should not be disregarded. In these cases, a nutraceutical approach may be a better option. Nutritional supplements effectively treat moderate dyslipidemia, and they have fewer side effects than statins. The most widely studied and used nutraceuticals are extracts of red yeast rice, berberine, phytosterols, and omega-3 fatty acids.

The Benefit of Probiotics on Cholesterol Levels

Available data suggest that the intake of selected probiotics, incorporated into yogurt or fermented milk, can significantly reduce total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C). 

Probiotic strains that show high biliary salt hydrolase (BSH) activity, such as Bifidobacterium longum BB536, may help lower cholesterol and LDL cholesterol levels by reducing intestinal cholesterol reabsorption. However, these probiotics may not be practical for long-term use. Therefore, incorporating these probiotics into pharmaceutical forms, in combination with other nutraceuticals, may improve adherence and efficacy in managing cholesterol.

This present study evaluated the efficacy and safety of a nutraceutical combination containing Bifidobacterium longum BB536, RYR extract, niacin, and coenzyme Q10 to improve LDL-C levels as the primary outcome. Additionally, clinical and experimental markers of CV risk like triglycerides, high-density lipoprotein-cholesterol (HDL-C), changes in total cholesterol (TC), apolipoprotein B (apoB), and others were also evaluated as secondary end-points.

The Study Method on Probiotics for the Management of Cardiovascular Risk

This study covered 12-week treatment, was double-blind, and placebo-controlled. Thirty-two subjects in primary CV prevention and low CV risk completed the study. They were randomly allocated so that 16 took the placebo and 16 received the nutraceutical product Lactoflorene Colesterolo®, which contains Bifidobacterium longum BB536, RYR extract, 16 milligrams (mg) niacin, 20 mg coenzyme Q10. Both placebo and active treatment were packaged in a sachet to preserve probiotic integrity. Following the intervention was a final four-week follow-up period.

Subjects were instructed to follow a regular caloric/low-saturated fat diet during the entire treatment period. They underwent a fasting blood sampling and a complete clinical examination, height determination, body weight, waist circumference, heart rate, and arterial blood pressure.

The Results

12-week treatment with the nutraceutical combination, compared to placebo, significantly reduced TC, LDL-C, non-HDL-C, and apoB. The nutraceutical combination significantly reduced the lathosterol-to-TC ratio. In contrast, the campesterol-to-TC ratio and sitosterol-to-TC ratio did not change, suggesting a synthesis reduction without increased cholesterol absorption. No adverse effects and a 97% compliance were observed.

The Conclusion

Bifidobacterium longum BB536 and RYR extract safely, effectively, and considerably improve the lipid profile that tends to form fatty plaques in arteries. Low CV risk subjects and those with borderline hypercholesterolemia tolerated the combination well.


Nutraceutical Approach for the Management of Cardiovascular Risk – A Combination Containing the Probiotic Bifidobacterium Longum BB536 and Red Yeast Rice Extract: Results from a Randomized, Double-Blind, Placebo-Controlled Study

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