Nutraceutical Clinical Trial to Evaluate the Effects of Different Blends in Cognitive Functions of Healthy Volunteers

It is indicated in numerous studies, that the content of fruits and vegetables, and therefore of the antioxidant compounds present, have a great capacity to neutralize free radicals, avoiding and preventing the deterioration of aging and degenerative diseases. The main effects tested are reducing the adverse effects caused by air pollution and free radicals that this causes in the organism that decreases oxidative damage, or exerting the ability of anti-inflammatory and neuroprotective effects. For example, in patients with kidney disease undergoing hemodialysis, a red grape supplement rich in polyphenols has demonstrated the ability to reduce the damage caused by oxidative stress.

The amount of bioactive compounds with antioxidants that are beneficial to the body varies according to the fruits and vegetables in question. For example, the pomegranate has a better antioxidant capacity than an apple and has values very similar to the different types of berries. This capacity depends on the amount of consumption of each of them, as well as the duration of consumption.

The mechanisms of action of this antioxidant activity in the body of the bioactive compound compounds that fruits and vegetables contain, have been determined in different previous research studies. In all cases, the antioxidant capacity shown by different fruits and vegetables depended on the concentration of polyphenols and enzymes of the kinase chain. For example, in the case of the prevention and control of type II diabetes, the main mechanism is diabetes by inhibiting the enzymes involved in the digestion of carbohydrates such as α-amylase or α-glucosidase or reducing agents. inflammation in diabetes with compromise in the metabolic syndrome and obesity with the corresponding oxidative stress.

In other cases, the effect of the combination of any of them has also been proven. Although the effect of these is positive, for example in the case of pomegranate and lemon, it shows that there is a positive synergy in both, the effect of the combination being better than separately The intervention of fruits and vegetables in cognition, for example, the improvement is associated with the decrease caused by age, shows a greater relationship in the case of flavonoids and especially anthocyanins and flavones.

The contracted would be in charge of the implementation and development of the following parts of the study, as well as the management and processing of obtained data, writing of scientific articles and help with the group's research tasks.

Study design. The contracted would carry out the recruitment phase. The randomized study, stratified by sex, crossed and controlled with placebo, designed to evaluate the effect of the daily intake of a dietary supplement on cognitive function and psychological well-being in comparison with placebo.

Duration of the study

• Recruitment phase: the recruitment of volunteers for the study will be carried out during the 2 months prior to the start of the intervention period. Volunteers will be recruited through email, information sessions, announcements etc.
• Selection phase: the Informed Consent sheet will be given to the volunteers so that, once they understand everything about the study, they agree to participate in the study.

The subjects will be evaluated and previously interviewed at the beginning of the study to know if they meet the inclusion / exclusion criteria.

• Product consumption (intervention period): Volunteers will be randomly divided into two similar groups (N1 = 50 and N2 = 50). The intervention period is divided into two phases of 16 weeks each, including a washout period of 4 weeks between the two phases.

Control appointments (the contracted will be responsible for monitoring and citing them): each volunteer will be controlled during the intervention period through 4 visits throughout the study. The visits will be made at the beginning and at the end of both phases of intervention. A period of time of ± 4 days will be established to make the visits. During each visit, determinations will be made regarding the different parameters studied.