A global elderly and aging population has significant impacts, not only in terms of individual health risk but in terms of societal pressures and issues. The Chief Commercial Officer at Atlantia Clinical Trials, Barry Skillington, and long-term Atlantia clinical trial expert Emily Goodbody explore how an aging population is analyzed, looking into the future of how the food and nutraceutical market could used to tackle the rise of healthy aging.
With a suggested three-pronged model of education, healthy-aging marketing, and building trust in the product, Barry and Emily consider that this space is freeing up for the future of clinical trials and the wider world.
Please could you introduce yourself and outline your role at Atlantia Clinical Trials?
BS: My name is Barry Skillington, and I am the Chief Commercial Officer at Atlantia Clinical Trials.
EG: My name is Emily Goodbody. I have an MSc in Clinical Nutrition and have worked with Atlantia for over six years. I have worked on a multitude of clinical trials in different health areas and am involved in the management and day-to-day running of the clinical trial.
What is the current status of the world’s population in terms of age?
BS: The world’s population is aging, and several demographic studies have shown that the speed at which populations are aging is increasing faster than we expected. In a study conducted by the United Nations, the variable represented is the percentage of 65 years of age or older within the total population of countries in 2019. If the same map is projected out to 2050, it can be seen that some of the most populated countries in the world are reaching similar levels of population aging.
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There are inherent differences in population growth across these countries. In fact, a group of people aged 65 years or older is the fastest-growing age group, and the projections of the United Nations are that this segment will be over 2 billion people by the start of the 22nd century in the year 2100.
Another observation is that in 2018, for the first time in human history, people aged 65 or over outnumbered children under five years of age worldwide. Between 2019 and 2050, the global number of people aged 65 or over is projected to be more than double, while the number of children under five is projected to remain relatively unchanged. Consequently, these projections indicate that, in 2050, there will be more than twice as many older people as there will be children under five. Moreover, it is expected that, in 2050, the 1.5 billion people aged 65 years or over will outnumber adolescents and youth aged 15 to 24 years. That is 1.3 billion people.
How is this aging population divided by countries?
BS: If we think of the divisions by country, all 201 countries or areas with at least 90,000 inhabitants in 2019 are projected to see an increase in the proportion of people aged 65 or over between 2019 and 2050. At a global level, in 2019, approximately 9% of people are aged 65 and over. The proportion of older people in the world is projected to reach nearly 12% in 2030, 16% in 2050, and it could reach nearly 23% by 2100.
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Europe and North America had the largest aged population as of 2019, with 18% aged 65 or over, followed by Australia and New Zealand with a combined 16%. Both regions are continuing to age further. Projections indicate that, by 2050, one in every four people in Europe and North America could be aged between 65 and older.
How will this aging population interact with other social trends to impact older people?
BS: If we consider this as a percentage change in the world’s population by age, the changes follow an exponential curve in which the group that will increase the most is by far the 100+ years, which will grow at over 1004%. Aging is taking place alongside other broad social trends that will affect the lives of older people. Economies are globalizing, people are more likely to live in cities, and technology is evolving rapidly.
Demographic changes in families mean that there will be fewer older people with families to take care of them. People today have fewer children, are less likely to be married, and are less likely to live with older generations. With the declining support from families, society will need better information and tools to ensure the well-being of our elderly. This segment of over-65’s is expected to increase considerably in the next few decades.
What is this demographic change attributable to?
BS: The remarkable improvements in life expectancy over the past century are part of a shift in the leading causes of disease and death today. At the dawn of the 20th century, the major health threats were infectious diseases and parasitic diseases that most often claimed the lives of infants and children.
Currently, non-communicable diseases, which more commonly affect adults and older people, impose the greatest burden on global health. The potential for an active, healthy old age is tempered by one of the most daunting and potentially costly consequences of ever-longer life expectancies. That is the increase in people with dementia. The cause of dementia is mostly unknown, but the final stages of this disease usually mean the loss of memory, reasoning, speech, and other cognitive functions.
How is data collected on dementia?
BS: The World Alzheimer Report in 2019 is the world’s largest survey on attitudes to dementia, as well as expert accounts and case studies from across the world. The London School of Economics and Political Sciences has conducted research across 155 countries and territories, with over 70,000 people completing the survey. It spans four demographic groups; people living with dementia, carers, healthcare practitioners, and the general public.
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Some key points in the report are that almost 80% of the general public are concerned about developing dementia at some point, and one in four people think that there is nothing we can do to prevent dementia. 35% of carers across the world said they had hidden the diagnosis of dementia of a family member. Over 50% of carers globally say their health has suffered as a result of their caring responsibilities, even whilst expressing positive sentiments about their role. Almost 62% of healthcare providers worldwide think that dementia is part of normal aging, and 40% of the general public think that doctors and nurses ignore people with dementia.
What does the data reveal about how consumers are approaching the aging process?
BS: People no longer have a passive attitude towards aging. Data shows us that seniors around the world want to remain active, independent, and at home for as long as possible. To continue to feel confident about their looks and stamina, mature consumers are paying more attention to their skin and hair regimes, their overall health, well-being, mental agility, and personal style.
Beauty and healthy aging are no longer just associated with image and fashion but are more and more linked to lifestyle and how consumers feel about themselves. As a result, older consumers are taking a proactive and holistic approach to their health, recognizing the need for balance in emotional well-being with keeping their minds sharp and bodies active. This is driving demand for a range of health and wellness products and services. Healthy living now represents a core lifestyle shift. Wellness is all-pervasive.
What are the three core areas identified in elderly healthy living?
BS: The three core areas identified in elderly healthy living are prevention, nutrition, and lifestyle. Many of the main axis consumers are now looking to tackle their outward appearance. That is the use of anti-aging products and supplements, cosmetic treatments, stylish clothing and accessories, health and well-being, that will be disease prevention through self-care and good nutrition, keeping fit, monitoring your body weight, emotional well-being, and mental agility. This is also seen in populations retiring later: people are learning new skills at older ages, volunteering, and continuing their brain training.
What is the role of nutraceuticals and functional foods within the healthy aging sector?
BS: A recent study published by Mintel highlights that nutraceuticals and functional foods may have an exceptional positioning within the healthy aging sector. At present, claims addressing senior health are very scarce in food and drink launches across almost all product categories. Aging populations may open opportunities for health claims in food and drink that are relevant to these consumers, such as cardiovascular, eye, bone, brain, and digestive health.
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40% of US consumers aged 18 to 34 agree that preventing disease or illness motivates them to eat healthily, suggesting that many younger consumers are already thinking about the link between diet and disease in later life. However, data from Lightspeed/Mintel reports show that only 50% of those aged 55 and over are thinking seriously about how nutrition can prevent illness and extend their healthy life term. This is a huge opportunity for the FMCG sectors, and nowhere is this opportunity greater than in the food and nutraceutical market.
How should nutraceutical companies reach their maximum potential?
BS: To reach their maximum potential, nutraceutical companies need to tackle three challenges as per research conducted by Mintel. The first of these is to educate healthcare professionals on nutraceuticals. Consumers are considerably influenced by their doctors in terms of nutraceutical purchases, but paradoxically, their doctors may have little awareness of them based on their medical education. Investing in practitioner education may forge trust, leading to product recommendations.
Nutraceutical brands should leverage the expertise and trust held in healthcare professionals’ opinions to support consumer understanding of products, develop resources about nutraceuticals that support clinicians’ professional development, and enhance their clinical work. Evidence-based human research provides the fastest and greatest boost to this end.
The second pillar is using nutraceuticals in the healthy aging space. Formulators should invest in the ingredients that are proven life extenders associated with disease reduction and enhancement of cognitive well-being.
Prevention and maintenance of current health remain strong drivers for purchasing nutraceuticals across the lifespan. Nutraceuticals that support healthy aging and senior consumers’ dietary and nutritional leads will prove very popular in a world where populations are aging and actively looking for critical alternatives to drugs. The third pillar would be building trust in nutraceuticals.
How are nutraceuticals delivered?
BS: Most nutraceuticals rely on traditional delivery formats, such as tablets, capsules, and powders. However, recently, the advent of new delivery systems such as smart packaging, dosing caps, timed-release technology, and micro-encapsulation has opened up a host of new potential formats that will appeal to aged consumers’ need for simplicity and efficacy.
Therefore, they want products that are easy to use and have proven benefits. This, coupled with better regulation, which is very important, appropriate marketing to that segment, and validated human clinical evidence, can increase consumer trust in these products.
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A recent report from Euromonitor highlighted that putting clinical evidence at the forefront helps gain consumer trust, and providing tools to see benefits is key to driving deeper engagement. Examples of this, in recent times, are the launch of products with apps being launched in parallel to the products that allow consumers to track online the efficacy of the products for themselves and on themselves.
Several of these products have been launched in recent times on skin health. They can see valid, tangible results before their eyes and report those results online using the app. This example of technology, in parallel with new product launches, is becoming somewhat of the norm.
Though new at the moment, this has a real place in the future: such tech is playing right into the current trend where consumers want to see results; they want to see results for themselves. Validated clinical evidence is the way forward.
How should human clinical trials take place?
BS: Randomized human clinical trials are considered the gold standard of evidence for the scientific substantiation of claims by EFSA and the FDA. So RCTs add medical knowledge and provide the effectiveness of interventions for disease prevention.
All clinical trials should be conducted using good clinical practice (GCP). With appropriate human subject protections, the HSPs, and all products in human testing should be produced under GMP practices using well-established quality management systems. The informed consent process is very important to make sure that you have the consent of the volunteer who is partaking in the trial. Trial registration is very important, as well as most of these other points in terms of risk management and adhering to GCP throughout the entire process.
What are the differences between food trials and pharma trials?
BS: Many people are aware of pharmaceutical trials, or drug trials, which have been happening for centuries, but food trials are both run and present differently in terms of the outcome and the process. Foods largely look at a health effect, whereas pharma looks at a highly purified and specific disease effect. Foods evaluate a health benefit, while pharma evaluates treatment effectiveness. Food is exploratory, and there is a need to incorporate the tested food into the normal dietary backgrounds of people in the trials.
They often do not have pharmacokinetics (PK) or pharmacodynamic (PD) details available, and they are designed in a free-living environment. The pharma world is explanatory as opposed to exploratory.
In terms of recruitment for food, they are smaller populations with self-described illnesses or near-illness, and in pharma, they are large populations of patients with specific diseases.
In terms of length and phases, generally, foods have only one phase - a single phase - whereas drugs have a four-phase and can take several years to complete, while a food trial will take anywhere from months up to a year to complete.
The costs - whilst arbitrary - very much depend on what is being tested. Food trials are much, much lower in cost. A cost per subject is generally estimated between $3,000 to $10,000, very much varying on what is being tested. That will give you a total cost of somewhere between $100,000 and $3 million. In the drug world, they are much more expensive. A per-subject cost can range between $30,000 and $50,000, and total budgets for drug trials run between $1 million and $50 million, and in some cases, far beyond. They can take years to develop, and while the effect size is much more targeted in drugs, there is a broader general audience in the food space.
In terms of label claims in both camps: for food, the label must be truthful, not misleading, and based on scientific evidence, according to both EFSA in Europe and the FDA in the US. In the drug space, information is used as a safety parameter and a description of effectiveness as opposed to a truthful statement.
What is the clinical trial process?
BS: Lots of trials run in a very similar manner, even though the activities within the trial vary massively based on what the trial is reporting on. The design phase is first, in which the protocol is written, the research documentation is gathered, regulation sense-checked, and then the ethics process is begun, in which ethics committees oversee all trials to make sure that safety parameters for volunteers are being upheld.
For recruitment, we recruit the subject database, we conduct the study visits, we analyze the results collected, and then we report on the results that were analyzed, and that will lead to the positive or negative output of a trial. In all trials, there is typically more than one outcome. There is a primary outcome, and then there could be several secondary outcomes. In many cases, there would be several exploratory outcomes that will inform future work or future trials.
What are the main singularities around a randomized control trial in elderly populations?
EG: Atlantia undertook a study, the main goal of which was to assess the efficacy and tolerability of a food ingredient in older adults at risk of acute respiratory tract infections during the winter season. The study population comprised 600 older adults, so we recruited subjects over 65 years with an increased risk of seasonal ARTIs.
The population reflected the general population of older adults, and we ensured that adequate representation of subgroups who had an increased risk of ARTIs. These factors included age, nutritional status, former and present smoking status, and certain comorbidities, which included frailty, asthma, and COPD.
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During the screening process, an exhaustive list of exclusion criteria was used, which was determined to ensure the sample represented the general population and also was used to maximize the study compliance. This study was a multicenter randomized, double-blind placebo-controlled parallel study. The study involved the participants coming in for four visits over 10 months.
The population was divided into three arms. We had two different treatment doses, a high dose and a low dose, and the placebo. Subjects who met the eligibility criteria following the screening visit were randomized on a one-to-one basis.
What else was relevant within the study?
The study also took into account the subjects’ intention to be vaccinated or being vaccinated, malnourished or risk of malnutrition cohorts, respiratory diseases, which included COPD and asthma, and also the different age cohorts, so 65 to 69 years, 70 to 74 years, 75 to 79 years, and 80 to 84 years, and also 85+ was analyzed.
The randomization was carried out using an interactive web response system, and this used a minimization protocol. The minimization randomization is a method of randomization that allocates subjects into treatment groups that best maintain balance in prognostic factors. It is effective even in small sample sizes and with multiple prognostic variables.
Apart from the data points collected during the visits, an app was also developed. This app was used to collect data points continuously throughout the study. This was a daily diary, which these subjects used to record information. This included information about the consumption of their product, any adverse events that they might have had between visits, any medications that they would’ve used, and any doctor visits. It was also used to track whether a subject had an ARTI, and this was done using the Jackson questionnaire.
If a subject met certain criteria on the Jackson questionnaire, they were instructed to complete the Wisconsin 24 and record their temperature. This was done until they recovered from the ARTI symptoms. If a subject recorded that they had an ARTI, the site was alerted via the app, and this led to a home visit, which was organized by Atlantia or the partner site, and a healthcare professional was sent out to the subject to confirm the diagnosis of the ARTI, and also to carry out certain procedures in the case of a positive diagnosis.
In Atlantia, 350 participants were recruited, and a total of 193 subjects per group finished, so that was a low dropout rate of 3.5%. In terms of the per-protocol and the intention to treat populations, approximately 200 per group were analyzed, and not all of them were allocated to the per-protocol group. The data analysis is still being conducted at the moment, so the results are not yet available.
What do you think should be the main takeaways in this area?
BS: Population aging seems inevitable. Companies targeting this very profitable segment might be able to get into a competitive advantage position relatively quickly. Disease prevention through nutrition is at the center of healthy living. However, some challenges still need to be overcome, as we spoke about, in terms of healthcare professionals’ education, format innovation, and trust in the nutraceutical market.
Clinical trials seem to be an initiative that supports these three burdens. However, GCP principles need to be followed. The importance of identifying and selecting a trusted CRO partner is the key to success. That partner should be aware of new methods and technologies coming on stream, but also of the interactions between those and the study population.
In the case of elderly populations, recruitment processes need to be adapted, a combination of clinic visits and home visits need to be employed, especially for those participants with reduced mobility, and the development of specific study technology, such as apps, that align with the characteristics of the population and their requirements. The apps we used were simplified, were smartphone-enabled, and took a very short amount of time out of volunteers’ daily ongoings.
About Atlantia Clinical Trials
Atlantia Clinical Trials Ltd is a CRO that specializes in conducting studies on foods, beverages, and supplements for companies worldwide that want to scientifically validate their functional ingredients to support an: EFSA (European Food Safety Authority) Health Claim; FDA (Food & Drug Administration) Structure Function Claim; or General Product Marketing Claim.
Atlantia works with world-leading scientists (among the top cited 1% internationally, in the areas of digestive health and functional foods) at the: APC Microbiome Institute in University College Cork, Ireland; Teagasc, Moorepark, Ireland, and recognized centers of excellence globally.
Atlantia runs and operates its own clinic sites and conducts all studies to ICH-GCP standard (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice). Its team includes physician experts in digestive health, mental health (psychological stress and cognition), cardiovascular health, sports performance, metabolic disease, bone health, immune health, and healthy ageing. The clinical team also includes project managers, research nurses, nutritionists, certified sports trainers and lab researchers.
Atlantia manages all elements from protocol design, placebo manufacture, recruitment, and study execution, to sample and data analysis, statistics, and report/dossier preparation to provide a service that is technically, scientifically, and clinically superior.
The clinical studies cover a broad spectrum of functional food and beverage categories, such as dairy, cereal, probiotics, different protein forms, infant-specific foods, vitamins/minerals, plant or marine extracts, and medical foods.
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