Following the coronavirus outbreak in early 2020, consumer demand for the classical immune system supporting ingredients such as vitamins C and D or zinc caused products to be sold out in pharmacies and drug stores. Food business operators (FBOs) had thus to ramp up production to catch up with the increased demand. This alone indicates that consumer interest in self-care products is exceptionally high. IRI, who tracks US multi-outlet sales, including in mass market, grocery, drug, and convenience stores, reported that in the first week of March 2020, sales growth for dietary supplements in the US soared to above 35%, with substantial increases for multivitamin products such as zinc.1
Although food ingredients and supplements are not intended for disease treatment or prevention, they may be of great importance in supporting general well-being and increasing the body’s resilience to health threats such as COVID-19. The products are readily available to the consumer and have very good tolerability profiles. In the current health crisis, and with consumers getting increasingly aware of their health, it is highly important for the self-care health industry to deepen consumers’ understanding on the health benefits of their products. So, generating convincing clinical evidence is key. Clinical units and CROs specialised in research involving natural ingredients in generally healthy study populations, such as analyze & realize GmbH, may provide adequate solutions as regards the design of the trials being able to demonstrate the studied effects as well as points to consider during the actual study conduct and outcome evaluation process.
And indeed, clinical research has since been directed towards substantiating the role of vitamins, minerals, and other food ingredients and supplements in COVID-19 management. For example, a link between novel coronavirus infection and vitamin D levels has been reported,2 with the relative risk of a positive COVID-19 test result increased in individuals with a deficient vitamin D status, even when taking into account other relevant factors such as present comorbidities. The relevance of research on vitamin D in relation to COVID-19 is clearly reflected by the number of clinical trials registered in the ClinicalTrials.gov database3 that returns 64 hits as of 20-Nov-2020.
Another ‘hot topic’ is researching the role of vitamin C in COVID-19 management, with 46 clinical trials on this topic registered on clinicaltrials.gov as of 20 November 2020. A recent review4 reported the finding of depleted vitamin C levels in serum and leukocytes during the acute stage of the infection and further described its multi-level potential, including beneficial effects on immune reaction to the viral infections, as well as antioxidant and anti-inflammatory effects (relevant for counteracting the cytokine storm processes). Also, vitamin K has been investigated for its potential relevance in the amelioration of COVID-19 severity.5 The authors found a significant correlation between dephosphorylated-uncarboxylated Matrix Gla-Protein and the elastic fiber degradation rate in COVID-19 patients and suggested that a vitamin K deficiency may be linked to a decrease in activated matrix Gla protein, as well as anticoagulant protein S, leading to pulmonary damage and coagulopathy.
Since the outbreak of the pandemic, a number of new clinical studies with natural health products in relation to COVID-19 has been initiated.6 A search on the clinicaltrials.gov database returned 120 hits for the keywords 'dietary supplement' and 'COVID-19' (as of 20 November 2020); 39 hits alone were found for 'zinc,' 11 for 'vitamin B,' 11 for 'vitamin E,' 10 for 'probiotics,' eight for 'omega-3' (fatty acids), six for 'quercetin,' five for 'honey,' and four for 'selenium,' in relation to COVID-19. This is another indication for how the pandemic is driving the need for new products in the self-care space, which, in turn, drives clinical research.
Apart from the direct impact of the coronavirus on the upper respiratory tract, other health conditions have also aggravated due to the pandemic. Sleep disturbances or uncontrolled weight gain are common consequences of living with lockdowns, due to enforced inactivity and increased stress levels. Obesity is considered to be one of the preconditions that may increase the risk of a severe course of coronavirus infection, particularly since an NHS audit in the UK revealed that over three quarters of critically ill patients were overweight.7 Understanding this link may give incentive for consumers to start losing weight, and clinical research is called upon to provide substantiation for new products that can help. Moreover, many survivors of a COVID-19 infection are subject to long-term effects. One of these effects is an impact on mental health. Researchers found that 20% of survivors developed a psychiatric disorder such as anxiety, depression, or insomnia within 90 days after contracting the virus.8
Apart from the expected focus of clinical research on natural products that provide immune health benefits during the pandemic, it would be extremely relevant to intensify clinical research in other key health areas affecting the consumer such as coagulation system functioning, blood pressure regulation, glycemic control, weight management, sleep and mental health issues, gut microbiome etc.
While consumers continue to drive demand for innovative products as a way to fortify their health and although the research on the beneficial effects of food products in the relevant areas has been progressing, scientific evidence needs to be continuously expanded. Now, more than ever, having products supporting their health benefits with firm clinical research will increase consumer confidence and brand trust.
- Meltzer et al. Netw Open. 2020
- Abobaker et al. Pharmacol. Rep (2020).
- Janssen et al. British J Nutr 2020
- Matteo et al. Foods 2020, Michienzi & Badowski Drugs in Context 2020
- ICNARC report on COVID-19 in critical care. 2020
- Taquet et al. Lancet 2020