The topic of the nutritional effects and health benefits of food supplements is becoming increasingly relevant in the healthcare sector. This is highlighted by the exceptional market growth observed in the sector in recent years, which is more than simple interest in taking these products and that involves an ever wider and more diverse public.

The scientific community is particularly focussed on the potential protective and therapeutic role of supplementing diets with micronutrients or functional compounds of plant origin, probiotics and prebiotics. As the scientists’ interest develops, so does the involvement of regulatory bodies, which are responsible for ensuring the safety and efficacy of products classified as food supplements.

Let’s look more specifically at what the scientific review of food supplements involves and what advantages this provides.

Nutraceuticals and clinical studies

Nutraceuticals can be included in the sectors of pharmacology and nutritional sciences, which is why their effectiveness must be proven through tightly controlled clinical trials. In this context, nutraceuticals are therefore part of evidence-based medicine (EBM), i.e. medicine based on science that provides health professionals and patients with validated information and evidence of the effectiveness of individual products.

Thanks to these clinical studies, some nutraceuticals are highly recommended by medical science experts. Significant examples include vitamin D for the prevention of osteoporosis, omega-3 fatty acids for the reduction of cardiovascular risk and group B vitamins to support the cardiocirculatory system and normal neurological functions. Group B vitamins include vitamins B1, B2, B6 and B12, which are involved in the production of red blood cells and help regulate homocysteine levels. Similarly, formulations that combine various nutraceuticals can positively influence different physiological mechanisms, favouring a more holistic and integrated approach to the health of the individual.

Evidence-based approach: the clinical trial process for food supplements

Regulation (EU) 1924/2006 clearly defines the procedures for approving a claim related to nutraceutical products. As mentioned above, nutraceuticals are where pharmacology and nutritional sciences overlap and, therefore, tightly controlled clinical studies are needed to prove the effectiveness of nutraceuticals. These trials may require pilot studies, in order to obtain detailed information on the desired outcomes. The recruitment of participants for these studies can be challenging, because the individuals needed must lead a healthy lifestyle and must be willing to participate in regular monitoring for data collection.

The challenges in studies on food supplements are many, but they can be managed with a well-structured experimental design. For example, trials should include, where possible, a placebo comparison group. In addition, conducting research studies in different healthcare centres helps to detect potential demographic and environmental differences, increasing the reliability and generalisability of the collected data. Because of the heterogeneity of the subjects and the influence of environmental and lifestyle factors, studies on nutraceuticals often require statistically significant samples. It is also very often necessary to assess the interaction of nutraceuticals with drugs used for the same therapeutic purpose, examining synergistic or antagonist effects when used separately and combined. In this regard, our supplement for thecentral nervous system, Cogiton, is clinically designed to be used in combination with drugs administered for the treatment of Alzheimer’s disease, such as Donepezil. Because it contains specific ingredients, such as vitamins B2, E, C and selenium (Se), it protects the cells against oxidative stress and mitigates the symptoms associated with this type of damage.

Why choose evidence-based food supplements

In recent decades, considerable scientific evidence has confirmed how a person’s diet has a strong impact on physiological processes and pathological mechanisms. This effect is not limited to just the metabolic consequences of calorie intake and macronutrient composition, but also extends to the functional role played by various micronutrients.

For this reason, the most recent scientific research has turned to nutraceuticals, i.e. foods or their components that have beneficial effects on health. The effects of these products on physiological processes and cellular functions linked to major diseases have been studied and their protective action against oxidative stress has been analysed, as has their ability to rebalance metabolism, but also to support the intestinal microbiota and much more.

In addition to the already-known vitamins and minerals, the most studied substances include polyunsaturated fatty acids (in particular omega-3 EPA and DHA), phytosterols, polyphenols (such as anthocyanins, procyanidins, catechins, flavanols, resveratrol, curcumin), soluble and insoluble fibres which help regulate intestinal function (including prebiotic action) and protect the cardiovascular system, and strains of probiotic bacteria of the Lactobacillus and Bifidobacterium genera. There is also increasing interest in:

  • Ginkgo Biloba, a plant with known phytotherapeutic properties and a high content of flavonoids, which, thanks to its antioxidant function, blocks the free radicals responsible for oxidative stress;
  • Chromium picolinate, which supports normal macronutrient metabolism and blood glucose levels;
  • Lycopene, naturally present in many foods, which, with its antioxidant power, is an excellent ally to protect cells from oxidative damage.

It is therefore possible to say that the practical applications of these studies lay the foundation for the development of evidence-based food supplements, which are synonymous with quality and effectually help prevent body-damaging processes and, therefore, fight the onset or development of various diseases.