Meeting emerging needs in gastrointestinal health

An increasing body of research suggests that what we consume may not only influence the body, but also the mind

Without doubt, improving our gut health will positively enhance our general well-being. The digestive system is a complex part of the body, designed to retain nutrients and eliminate waste. Consequently, if digestion is difficult or compromised, our state of overall health is weakened. Furthermore, so-called gut health is receiving growing attention from researchers and clinicians, as what we consume may not only influence the body itself, but also the mind; thus, poor digestion may affect energy, mood, pain and allergies.

As a result of increasingly unhealthy dietary habits, stressful lifestyles and growing elderly populations, the incidence of chronic conditions and digestive and gastrointestinal disorders is on the rise. Sometimes, these conditions start as mild discomfort and it’s all too easy to ignore or underestimate them, which can be the first step on a dangerous journey towards chronic inflammation. Several studies have demonstrated the role of chronic, low-grade inflammation in the onset of many conditions, such as cardiometabolic and gut disorders. Related to this is a substantial amount of evidence that suggests many foods, nutrients and non-nutrient food components modulate inflammation, both acutely and chronically.1

The most common digestive disorders are a set of chronic or recurrent pains or discomfort in the upper abdomen, commonly known as functional dyspepsia (FD), the prevalence of which is noted to vary between 11% and 29.2% of the adult population. Symptoms are frequently correlated to meals and may include abdominal pain, bloating, early satiety, fullness, belching and nausea.2 FD is not life threatening and has not been shown to be associated with any increase in mortality … but its impact on people’s quality of life and healthcare services is proving to be considerable.3

In this scenario, driven by their awareness of the key role of nutrition, more and more people are trying to change their lifestyle by turning to healthy diets. Keen to increase their consumption of healthy nutrients, they’re also looking for natural approaches. In the specific area of gut health, consumer interest in remedies that improve digestive and gastrointestinal health has registered double-digit growth in recent years, which is expected to continue for the foreseeable future. Given the limited efficacy of the majority of conventional drugs, it is not surprising that up to 50% of subjects with FD seek out alternative therapies. As a result, several botanical supplements are being studied and reveal great potential. Derived from nature, Indena has developed various products that offer significant opportunities in digestive and gastrointestinal health applications: Prodigest, Meriva Curcumin Phytosome and Casperome.

Boswellia serrata

Natural digestive relief

Prodigest is Indena’s latest breakthrough for natural digestive relief, a good example of how an innovative approach supported by a strong scientific background may lead to a pioneering solution. Capitalising on the synergy between artichoke and ginger extracts, Prodigest is a patented combination of two standardised ingredients: a unique extract of artichoke leaves (Cynara cardunculus L.) and a similarly unique lipophilic CO2 extract of ginger roots (Zingiber officinale Rosc.). To develop Prodigest, Indena redesigned these two well-known extracts to create a product that is backed up by exhaustive clinical data supporting both its functionality (gastric emptying) and effectiveness (relief of discomfort). The inventive synergy of artichoke leaves and ginger extracts developed by Indena has been proven to be more effective than the two single extracts taken separately.

The efficacy of Prodigest in FD was confirmed in a clinical study conducted with 126 subjects. Those who received 120 mg of Prodigest’s active principles (100 mg of artichoke extract and 20 mg of ginger extract) twice a day before meals showed statistically significant (+34%) symptom relief compared with the placebo group during a short-term 14-day treatment, and the efficacy was maintained until the 28th day of supplementation. Furthermore, 86.2% of the treated subjects reported amelioration of FD, with a marked reduction of intensity (63.1%) compared with the placebo group (24.6%).4

Supported by long-term stability data, Prodigest is available in capsules and as a premix formulation. This new formulation enables Indena’s partners to reduce internal development activities and expedite the time-to-market of their own products, meeting the emerging needs of consumers. Similarly, clinicians also have at their disposal a food supplement of proven efficacy, with no side-effects, which meets the latest recommendations issued by the European Medicines Agency regarding the use of prokinetic drugs and the side-effects associated with them.

The yellow side of gut health

Silent chronic inflammation, even when associated with gastrointestinal conditions, is one of the big challenges of our time — and human beings need help to ensure that a natural inflammatory response does not turn into long-term low-level chronic inflammation. For example, there is extensive scientific literature noting that exercise-induced heat stress increases gastrointestinal damage and the risk of exertional heatstroke. This happens because during prolonged endurance exercise, blood flow is disproportionately diverted towards the skeletal muscle and skin.

A recent double-blind placebo-controlled human study conducted independently by a team of American researchers at High Point University (NC) shows that short-term dietary curcumin-based supplementation may be helpful in the maintenance of gastrointestinal barrier integrity and physiological strain responses during exertional heat stress.5 The study examined an acute supplementation regimen, wherein participants ingested five tablets (500 mg each) of Meriva Curcumin Phytosome or a placebo for 3 days prior to exertional heat stress (EHS). This dosing strategy was selected with reference to those used in two recent clinical studies demonstrating the positive effects of Meriva on healthy inflammatory responses to endurance cycling and on delayed onset muscle soreness.6,7

There were two major findings from the High Point University study. First, it demonstrated that Meriva Curcumin Phytosome supplementation may reduce the rise in core temperature (Tc), mean body temperature (Tb), heart rate (HR) and physiological strain index (PSI) during exertional heat stress. Second, it showed that these changes are accompanied by improved GI barrier integrity and associated cytokine responses — as indicated by the lower circulating concentrations of a known marker of intestinal damage, the intestinal fatty acid binding protein (I-FABP) — in post-exercise subjects supplemented with curcumin (58% versus 87% in the placebo group, p=0.002).

These data suggest that short-term dietary curcumin-based supplementation may help to lower EHS risk in non-heat acclimated individuals. This study was the first to examine curcumin for its potential benefits on system-level physiology responses during exertional heat stress. Meriva Curcumin Phytosome also showed proven benefits in Non-Alcoholic Fatty Liver Disease, the most common chronic liver disorder in the West, affecting 30% of the general adult population and up to 60–70% of diabetic and obese patients. The liver is an accessory digestive gland that detoxifies various metabolites, synthesises proteins and produces biochemicals necessary for digestion. Therefore, it is very important to keep the liver healthy. In a recent study, the efficacy and the safety of Meriva Curcumin Phytosome supplementation in fatty liver disorders were confirmed with the improvement of liver status after just 8 weeks of supplementation.8,9

Thanks to its specific properties, Meriva Curcumin Phytosome optimises bioabsorption levels according to the three basic parameters of effectiveness, tolerability with time and safety, thus representing a reference model for a new type of relationship between curcuminoids and health maintenance. Meriva is based on a natural and 100% food-grade delivery system (Phytosome) comprising a standardised turmeric extract containing the full bouquet of curcuminoids, not just curcumin. It stands as the most clinically documented bioavailable curcumin formulation (30+ clinical studies in 10 different conditions involving more than 2000 subjects).

Gum resin for gut health

Also in the realm of botanical supplements that can help to manage inflammation is Boswellia serrata gum resin, which has long been used in Indian and Chinese medicine for the treatment of arthritis, respiratory tract inflammation, diarrhoea and liver disorders.10

Recent pharmacological research has identified the active principles of the gum resin to be boswellic acids, a series of unique pentacyclic triterpenoids. Indena’s Casperome is inspired by modern research on Boswellia, which highlights the clinical efficacy of the whole bouquet of triterpenoid acids and their improved absorption. Casperome is a food grade delivery system (Phytosome) of triterpenoid-rich extract from Boswellia serrata, standardised by HPLC to a content of ≥25% triterpenoid acids. Its triterpenoid profile includes all 11 major boswellic acids and closely matches the profile of the natural resin.

The clinical efficacy of Casperome is supported by seven clinical studies that show improvement in inflammation-driven chronic conditions such as neuropathic pain (cervical and lumbar radiculopathies, lateral epicondylitis, tendinopathies). Notably, two recent clinical trials have also demonstrated the great potential of Casperome in gut health applications.11 In particular, the reduction of discomfort in supportive care for ulcerative colitis patients in remission was observed; in addition, the reduction of IBS symptoms, including abdominal pain, altered bowel movements, meteorism and cramps, was observed in subjects with mild irritable bowel syndrome.

Plants represent a rich source of new active principles, and botanical extracts are increasingly being used in different markets, including health foods and supplements. Quality control and the rigorous standardisation of these extracts is essential to guarantee the necessary safety and efficacy. Quality certifications have become fundamental for the main players in the market, with supporting scientific literature making a real difference: preclinical and clinical studies must be designed according to internationally recognised standard procedures and published in peer-reviewed scientific journals. This is the rigorous scientific approach that ingredient suppliers should undertake … and should be asking their raw material suppliers to provide every time they consider adopting an ingredient for a new formula.

References

  1. A.M. Minihane, et al., Br. J. Nutr. 144, 999–1012 (2015).
  2. N. Talley, et al., Gut, 45(2), 1137–1142 (1999).
  3. S. Mahadeva and K.L. Goh, World Journal of Gastroenterology 12(17), 2661–2666 (2006).
  4. A Giacosa, et al., Evidence Based Complementary and Alternative Medicine, Article ID 915087 (2015).
  5. M.C. Szymanski, et al., J. Appl. Physiol. (2017): doi:10.1152/japplphysiol.00515.2017.
  6. J.N. Sciberras, et al., J. Int. Soc. Sports Nutr. 12, 5 (2015): doi:10.1186/s12970-014-0066-3.
  7. F. Drobnic, et al., J. Int. Soc. Sports Nutr. 11, 31 (2014): doi:10.1186/1550-2783-11-31.
  8. Y. Panahi, et al., Drug Res. (Stuttg). 67(4), 244–251 (2017).
  9. Y. Panahi, et al., J. Cardiovasc. Pharmacol. 68(3), 223–229 (2016).
  10. M.Z. Siddiqui, Indian J. Pharm. Sci., 73, 255–261 (2011).
  11. L. Pellegrin, et al., Eur. Rev. Med. Pharmacol. Sci. 20, 2695–2700 (2016).

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