Current trends in biological research have indicated a strong link between health and diet. Nutraceuticals can be defined as concentrated extracts from food sources that provide health benefits including prevention of diseases and promotion of general wellbeing for sufferers of chronic diseases. Stephen De Felice coined the term “nutraceutical” in 1989. He defined it as food or a part of food with medicinal benefits, hence the amalgamation of food with pharmaceuticals. The category is broad, as it may include functional foods, dietary supplements, food additives, and more. 

Nutraceutical market:

According to one report, the size of the nutraceuticals market is expected to be USD $319.6 billion by 2025, with a projected CAGR of 6.70%, and another research report predicts it will be $722.49 billion by 2027. There are numerous giant companies in the nutraceuticals market, including  GlaxoSmithKline, DuPont, BASF, ADM, Kellogg, Kraft Foods, Nestle, and PepsiCo, but there are also interesting smaller companies like Ixoreal Biomed, Ingredia, Sabinsa, Sirio, Arjuna Natural, Nating Italia, Active Pharma, Indena, and Pharma Nord. 

Health implications:

A major driver for the nutraceuticals market is the prevalence of chronic disease, with a large number of consumers looking at their diet to help manage symptoms. For instance, according to Monash Food Innovation, the number of probiotic products grew to 1,800 in 2016 from 100 in 2002 due to growing awareness of chronic GI disorders and the understanding that a healthy gut microbiome is essential for neurological, cardiovascular, respiratory, and psychological wellness. Management of chronic diseases through the use of nutraceuticals is an evolving area of research. 

The CDC estimates that 6 out of 10 people in the United States suffer from at least one chronic disease, and these diseases have a huge social, economic, and mental impact. Major chronic diseases include cardiovascular, neurological, gastrointestinal, and autoimmune diseases, cancer, and diabetes; and in some countries, more than 50% of the population are consumers of nutraceutical products. 

Cardiovascular diseases:

Cardiovascular diseases (CVDs) are one of the major causes of death globally. Nutraceuticals can be applied in areas like reducing cholesterol, reduction of plaques, and lowering blood pressure.

Omega-3 fatty acids are known to be required for heart, brain, and eye function, and they reduce the risk of CVDs. Numerous companies produce omega-3 fatty acids, such as Golden Omega, BASF, Qualitas Health, Bioriginal, OLVEA Fish Oils, and Icelandiect. Apart from the preventive capabilities of fatty acids, some products can aid in the enzymatic breaking of fibrin in blood clots. Nattokinase is an enzyme derived from a Japanese fermented food called natto that is released by Bacillus subtilis. This enzyme possesses strong fibrinolytic activity via inactivation of the plasminogen activator inhibitor-1. Nattokinase is produced by Contek Life Science, Daiwa Pharmaceutical, and the Japan NattoKinase Association. 

Natural antioxidants like coenzyme Q, or ubiquinone, protect cells and organ systems against reactive oxygen species, and coenzyme Q10 supplementation is regarded as a preventative measure for CVDs. Coenzyme Q10 is reportedly one of the most consumed supplements in the United States, generating $1 billion in annual sales globally. One example of a bioavailable formulation of coenzyme Q10 is Indena’s Ubiqsome.

Neurodegenerative diseases:

Inefficient glucose metabolism is a sign of many neurodegenerative conditions. To combat this situation, companies are developing new solutions that use the ketone system to fuel the brain. Cerecin’s tricaprilin is a triglyceride capable of inducing ketosis and enhancing mitochondrial metabolism. It is currently under Phase 2 trials. The targets of tricaprilin are Alzheimer’s disease, migraine, Parkinson’s disease, and epilepsy.

It is estimated that by 2025, 22 million people will suffer from Alzheimer’s disease. Nutraceuticals,  among multiple factors including age, genetics, environment, and lifestyle, may be one of our best chances to prevent this epidemic. Among prevention studies, nutraceuticals such as Gingko biloba and Huperzia serrata extracts are interesting to note, along with phosphatidylserine, acetylcarnitine, and coenzyme Q10.

Gastrointestinal disorders:

Currently, GI heath is one of the priorities of the nutraceutical industry, and the probiotics market is expected to reach USD 53 billion by 2023. 

Scientists recently came to a consensus about the definition of fermented food, where the word “probiotic” is to be used when the fermented food has live microorganisms that have been proven scientifically to have health benefits.

Here are some interesting collaborations and projects on probiotics:

• In December 2020, Kraft Heinz and APC Microbiome Ireland joined hands to work on new natural cultures for food fermentation.
• GanedenBC30, which stands for Bacillus coagulans GBI-30, 6086, is a natural probiotic that aids in digestive and immune health, with possible roles in protein utilization. It has a natural protective outer shell that makes it pH resistant, providing a higher shelf life compared to the usual Lactobacillus and Bifidobacterium probiotics.
• Holobiome is working on developing probiotics and microbial therapeutics that will help people with depression and other mental disorders. In 2019, a group of scientists published results showing that people with depression lack two definite bacterial species in their gut, and these species influence our neurons and brain. They found that some groups of bacteria, such as Bacteroides, produce a neurotransmitter called gamma-aminobutyric acid (GABA) that reduces neural activity. The findings have been patented, and the group is working to bring the best product in the market.

Next-generation probiotics:

Next-generation probiotics (NGPs) are making their entry into the market due to the ease of sequencing the microbiota. NGPs have the potential of being categorized as live biotherapeutic products, which are treated as drugs, and to be targeted for specific health conditions. NGPs that are being investigated for use in treating chronic health conditions include Parabacteroides goldsteinii for the amelioration of smoking-induced chronic obstructive pulmonary diseases, Streptococcus spp. to prevent the progression of chronic kidney disease, and Akkermansia muciniphila to improve the metabolism of obese and diabetec people.

Future needs:

Currently, there is a need for more clinical trials on nutraceuticals to separate the best from the rest. Organizations like Vizera, Atlantia Food Clinical Trials, and Nizo are helping nutraceutical companies design clinical trials and more. For example, Atlantia is recruiting for several food clinical studies, including investigations into the effects of certain foods on prediabetes, memory impairment, and constipation. 

There are a wide range of nutraceutical products that require more in-depth scientific investigation and adaptation based on region, population, food habits, and other relevant criteria. In a review published in British Journal of Clinical Pharmacology, the authors suggested that if clinical evidence is established, then the product can be designated as a nutraceutical rather than a food supplement. The mechanism of action, along with its pharmacokinetics and pharmacodynamics, should be well established. Finally, the efficacy and safety of the product should be evidenced by proper clinical trials.

The market requires more regulation to ensure safety from fraudulent nutraceuticals. There is a very urgent need to regulate products at the interface of pharma and nutrition. The regulations vary widely among different countries. In the United States, the FDA recognizes the term “nutraceuticals,” and they have been separated from conventional food and drugs under the Dietary Supplement Health and Education Act of 1994, which states that the safety of the product must be ensured by the manufacturer before it is marketed.

In the European Union, the product needs to be certified by the European Food Safety Authority (EFSA), which does not differentiate between food supplements and nutraceuticals. Any claims of health benefits of a food/nutrient product must be authorized in detail by EFSA before it is  marketed in the EU countries. In India, health supplements and nutraceuticals are overseen by the Food Safety and Standards Authority of India (FSSAI), whose rules are less stringent than those for pharmaceutical products, listing eight categories of such products. China and Japan each have their own functional food and nutraceutical registration processes, as do many other countries across the globe.

This lack of uniform regulations could affect the safety, quality, and quantity of products that are being produced. In 2019 India’s FSSAI issued new directives where all food safety commissioners have been asked to perform surveillance of all products under their jurisdiction due to increased false claims of health benefits. The FDA also took a stand in 2019 to update the regulations on dietary supplements to fight against the growing risk of false claims and illegal products. New directions  should be introduced by countries to guide the development of new nutraceutical products. Strict monitoring can ensure that the consumer market is not overwhelmed by false claims. 

Conclusion:

Nutraceuticals have the potential to reshape how we perceive food and medicine. They provide an opportunity for diversification of food medicines but require more research, new technology, clinical trials, innovative product formulations, and stringent, more uniform regulation.

Despite all the uncertainties, the nutraceuticals space is always evolving and bubbling with novel ideas. Innovations in the field of nutraceuticals that allow for fewer side effects, and provable health benefits will always be sought-after products for amelioration of diseases and other health conditions.

Featured image by Marco Verch – CC BY 2.0

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