Rome, February 21, 2022
In the coming months, the randomized, placebo-controlled, double-blind clinical study to measure the efficacy index of pomegranate extract combined with vitamins B and C
Esserre Pharma's virtuous supply chain to give value to the immunonutrition of a typical Mediterranean fruit, the pomegranate.
A new preliminary study, conducted by the University of Naples Federico II in collaboration with Esserre Pharma, highlights the role of pomegranate extract, a typical Mediterranean fruit, in combination with vitamins of the B and C groups in effectively combating prolonged or short-term fatigue - SF. A natural aid to overcome periods of exhaustion that interfere with normal activities and negatively affect the quality of life. The survey was conducted on consumers of food supplements and aimed at reducing fatigue: 78 subjects (21 men and 57 women) were recruited for one month to evaluate the efficacy and tolerability of this food supplement through internationally validated questionnaires for the assessment of the level of fatigue and quality of life. Consumers reported a significant improvement in their conditions without adverse effects in this period of time. Although further studies are needed, these preliminary data suggest the ability of a combination of pomegranate extract and water-soluble vitamins to alleviate short-term fatigue (SF). The publication is available at https://www.mdpi.com/2227- 9717/10/2/208. “We started from the results of several scientific studies, which attribute pomegranate properties as a “superfood”, and then we turned to people who had asked their pharmacist for a food supplement that would relieve them from the feeling of prolonged fatigue. This survey among consumers, conducted with a robust scientific approach, has highlighted very positive elements in favor of pomegranate in combating the feeling of fatigue” says Professor Maria Daglia, Professor of Food Chemistry, Department of Pharmacy of the University of Naples Federico II, one of the authors of the survey. “Pomegranate, in combination with B vitamins and vitamin C, has provided promising results as it seems to help in situations of non-pathological fatigue. Therefore, in collaboration with General Practitioners, the research will continue in the coming months, with a randomized, placebo-controlled, double-blind interventional clinical study, which can confirm the efficacy of pomegranate extract combined with water-soluble vitamins, against prolonged fatigue or short-term fatigue, highlighted by this first investigation.”
"For the first time, we have tested the effectiveness of a typical Mediterranean ingredient as a support for the immune system, unlike other ingredients often used that are of extra-Mediterranean origin. And it is also the first time that we have looked at pomegranate in relation to the immune system, especially today when our system is under attack not only by external agents, but also by the pandemic stress we have been subjected to for months" underlines Costanza Riccioni, Chief Scientific Officer Esserre Pharma. “The feeling of tiredness and fatigue is one of the typical manifestations of an altered immune system and can often present itself in the form of infections, inflammation or other types of stress. In other words, we are talking about immunonutrition, a concept whereby some nutrients, thanks to their anti-inflammatory activity, can help the immune system. In the case of pomegranate, this is possible thanks to its contribution of polyphenols. In fact, the activity of pomegranate extract, in preclinical studies, has been shown to reduce some biochemical markers of inflammation such as pro-inflammatory cytokines, interleukin-6 or hs-CRP - high-sensitivity C reactive protein”. “When we talk about circular economy, a true guideline for our research on raw materials from the Mediterranean basin, in the case of pomegranate we mean that the juice goes away entirely”, concludes Riccioni. “Instead, we use the peel but also other parts traditionally considered waste from the food industry. We are then planning other structured studies to understand, also with the use of biochemical markers of oxidative stress and inflammation, how the effect of pomegranate extract can reduce the values expressed by biochemical markers”. Short-term fatigue - SF short-term fatigue Fatigue can be defined as a state resulting from physiological and psychological stress that leads to a transient reduction in physical or mental performance (i.e. mental fatigue or physical fatigue). In turn, fatigue can be classified as prolonged fatigue (or short-term fatigue, short-term fatigue SF) or chronic fatigue (CFS). SF is a condition of non-pathological fatigue, which is also recognizable by the subject himself, and consists of the persistent or repeated incidence of clinically inexplicable fatigue events. Brief episodes of fatigue occur in 10–33% of the total population and SF, which can last from 30 days to six months, is also very common, occurring in about 5–8% of the general population, and can thus be considered a universal symptom expressed by the majority of the population. Fatigue can result from one or more pathological conditions, but it can also be a completely physiological condition related to lifestyle, lack of sleep or poor sleep, stress, family and professional worries and environmental factors, which make it difficult to identify the true cause. One of the most common causes of fatigue is increased physical work. Many studies have reported that fatigue induced by physical training results in a deterioration in sports performance. For example, cross-country skiers had reduced double-poling performance after a 25-minute trunk-fatigue exercise sequence, compared to 25 minutes of rest. Interestingly, the reduced performance appeared to be associated not only with muscular work, but also with mental factors. For example, table tennis players hit the ball with less attention and speed after completing a 90-minute cognitive task.
Fatigue is debilitating and often has significant economic consequences. A Dutch study found that 21.5% of adult workers reported prolonged fatigue, which can lead to lower productivity at work. In addition, many studies show that in Europe, tiredness while driving is the leading cause of death on the roads, and that drowsiness-related crashes are more serious and fatal than those where drowsiness is not the cause of the crash.
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