The drugs must comply with extensive regulations and go through clinical trials that prove that they produce the benefit they promise, with the fewest possible side effects. This is something that is guaranteed in any medicine that we buy in pharmacies. We can be sure that you comply with the regulations of the competent authority in your territory. For example, the EMA in Europe and the FDA in the United States. On the other hand, food supplements do not have to meet so many requirements.
They need to go through some safety and quality control testing, but not by clinical trials. Precisely for this reason, they sometimes use marketing tricks to make believe that they offer benefits that they cannot really get. However, there are manufacturers who, despite not having the obligation, choose to carry out these clinical trials to guarantee the efficacy of what they sell.
It is, for example, the Lanier Pharma case. A company made up of people with experience in the pharmaceutical industryin which they develop and market their food supplements with an aesthetic very similar to that of drugs. Boxes with a leaflet, letters in braille… But they also perform clinical trials of the products they promote.
Dietary Supplements and Clinical Trials
We live in a time when advertising continually bombards us with all kinds of food supplements, aimed at endless applications. There are some to sleep better, to have stronger hair, to improve mood, to strengthen the immune system…
And, of course, we also find a multitude of vitamin complexes, which promise in part a compendium of all of the above. However, many of these products are not necessary if there is no diagnosed deficiency. Vitamins can be of two types: water soluble or fat soluble. The first ones are released in the urine, so if we take them unnecessarily we are simply generating expensive urine. On the other hand, the latter accumulate in the tissues and, if they are sufficient with the diet, they can be found in too high doses, causing health problems.
Also, both vitamins and other micronutrients may not be as necessary as is sometimes advertised. In fact, according to a review of 884 studies on the subject recently published in Journal of the American College of Cardiologywith this type of products it is also necessary to establish a benefit/risk balancejust like with drugs. And this balance must be as individual as possible, because what is effective for one person may even be harmful for another.
It is clear that introducing the sector of food supplements, known in some cases as nutraceuticals, in clinical trials is not mandatory, but it is necessary. And it is that, as he explained to hypertextual the CEO of Lania Pharma, Guillermo Sada, is the best way to offer consumers products that really work. “There are a very large, heterogeneous and diverse offerwith many distribution channels and the final consumer often does not know how to distinguish if we are talking about a product with the quality of another”.
Collaborations with universities
In the case of Lanier Pharma, they have conducted clinical trials on a multitude of products. Soon, in fact, they are going to make a very interesting one of their immune system modulator product. It contains as active principle the β-1,3/1,6-Glucan. Beta glucans are generally polysaccharides known to be very good modulators of the immune system. They can activate it to act more effectively against a threat, but not too much. This is important, as drugs that overstimulate the immune system can be harmful, for example, to patients with autoimmune diseases.
The studies carried out on this substance show that, of all the conformations of beta glucans, the most effective is β-1,3/1,6-Glucan. For this reason, those responsible for this company have chosen this active ingredient for their immunomodulatory nutraceutical. They have conducted individualized clinical trials; but, in addition, they are currently beginning to develop another in collaboration with the University of Valladolidto check if the immunogenicity generated by COVID-19 vaccines may be better if administered in conjunction with this product. That is, the objective is to check if more antibodies are produced, with a longer duration. The clinical trial is about to begin, as it will take place during the administration campaign for the fourth dose of the vaccine, and the results could be very interesting.
Very Special Collagen Food Supplements
On the other hand, they have conducted clinical trials in search of collagen supplements that they are effective. Generally, those that are marketed are hydrolyzed collagen powders. This means that, when consumed, what is administered are the amino acids that make up collageneither. That is, each of the little bricks that make it up, as if they were Lego blocks. The problem is that, once in the body, these building blocks can clump together to build other proteins, not necessarily collagen. Therefore, it is usually a very ineffective food supplement.
Instead, this company has conducted clinical trials with unbroken collagenwhich is administered introduced in a matrix. This prevents its acidic pH from breaking down the protein as it passes through the stomach. Therefore, it arrives intact at its destination. And what is that destination? “At the intestinal level, it acts on an immune lymphoid tissue, which causes an immune reaction that stimulates the production of new cartilage,” explains Sada. “We don’t administer cartilage, but we provoke an immune reaction that causes new cartilage to be produced.”
They are not drugs, but the details are taken care of
The natural is not innocuous. And this is something that must be taken into account when taking any nutritional supplement or including herbal product. Can have contraindications or even interfere with drugs that are being taken
Unfortunately, since there is no strict regulation in this regard, It is not mandatory to declare it on the packaging. In addition, if clinical trials are not carried out, it is very difficult to establish these contraindications. Therefore, the path that they are following from this company, as well as from many research centersIt is essential to be able to take as many precautions as possible. A prospectus with these details is not required, but it can make all the difference.
That should be the drift of food supplements; so that, at least, we know why we take them and how we should do it. Not everything goes, even if the regulations are not the same as those for drugs.