Thought Leaders Barry Skillington and Emily Goodbody Cheif Commercial Officer and Clinical Trial Expert Atlantia Medical Trials

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 Official 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, plus building trust in the product, Barry and Emily consider that this space is freeing up for the particular future associated with clinical trials and the wider world.

Please could you introduce yourself plus outline your role at Atlantia Scientific Trials?

BS: My name will be Barry Skillington, and I is the Chief Commercial Officer at Atlantia Clinical Tests.

EG: My name is Emily Goodbody. I have an MSc in Clinical Nutrition and have worked with Atlantia for over six years. I possess worked on a multitude of medical trials in different health areas and am involved in the management and day-to-day running of the clinical trial.

What is usually the current status from the world’s populace in terms of age?

BS: The world’s population is definitely aging, and several demographic studies have shown that the speed at which populations are aging can be increasing faster than we expected. In a study conducted by the United Nations, the particular 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 certainly projected out to 2050, it can be seen that some associated with the most populated countries in the world are reaching similar levels of population ageing.

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There are inherent differences in population growth across these countries. In fact , a group of people aged sixty-five years or even older is the fastest-growing age group, as well as the projections of the United Nations are usually that this segment will be over 2 billion people by the start of the 22 nd century within the year 2100.

Another observation is that will in 2018, for the first time within human history, people aged sixty five or over outnumbered children under five years of age group worldwide. Between 2019 and 2050, the global number of people aged 65 or over is projected to be more than double, while the particular number of children under five is forecasted to remain relatively unchanged. Consequently, these projections indicate that, in 2050, there will be a lot more than twice as many older people as you will see children under five. Moreover, it will be expected that will, in 2050, the 1. 5 billion dollars people aged 65 many years or higher will certainly outnumber adolescents and youth aged 15 to 24 years. That is 1 . 3 billion people.

How is this getting older population divided by nations?

BULL CRAP: If all of us think of the divisions by country, all 201 countries or places with in least 90, 000 inhabitants in 2019 are expected to see an increase in the proportion of individuals aged sixty-five or over between 2019 plus 2050. At a global level, within 2019, approximately 9% of people are aged sixty five and more than. The percentage 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 human population as of   2019, along 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 within every four people in Europe plus North America could be aged between 65 and old.

How will this particular aging inhabitants interact with other social trends to impact seniors?

BS: If we consider this as the percentage change in the world’s population simply by age, the particular changes follow an exponential curve inside which the group that will increase the most is by far the 100+ years, which will grow from over 1004%. Aging is usually taking place alongside some other broad social trends that will affect the lives associated with older people. Economies are globalizing, people are more likely to live within cities, and technology is definitely 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 usually less likely to become married, and are less likely to live with old generations. With the declining support from family members, society will need better information and tools to ensure the well-being of our elderly. This segment of over-65’s can be 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 within the leading causes associated with disease plus death today. At the dawn from the 20th century, the particular major wellness threats were infectious diseases and parasitic diseases that most often claimed the lives of infants and kids.

Currently, non-communicable diseases, which more commonly affect adults and older people, impose the greatest burden upon global health. The potential for an active, healthful old age is tempered by one of the most daunting and potentially costly consequences of ever-longer life expectancies. That is certainly the increase in people along with dementia. The particular cause of dementia is mostly unknown, but the particular 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 biggest survey on attitudes in order 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 individuals completing the particular survey. It spans 4 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 will almost 80% of the general public are concerned about developing dementia with some point, and one within four people think that there is nothing we can do to prevent dementia. 35% associated with carers across the world said they had hidden the diagnosis of dementia of a family member. Over 50% of carers globally say their wellness has suffered because a result of their caring responsibilities, even whilst expressing positive sentiments about their role. Almost 62% of health care providers worldwide think that dementia is a part of normal aging, plus 40% of the general public think that will doctors and nurses ignore people with dementia.

What does the information reveal regarding how consumers are approaching the aging process?

BS: People no longer have the passive attitude towards aging. Data shows us that seniors around the globe want to remain active, independent, and at home for as long as possible. To continue to feel confident about their own looks plus stamina, mature people are paying more attention to their particular 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 plus fashion but are more and more linked to lifestyle and exactly how consumers feel about themselves. As a result, old consumers are usually taking a proactive and holistic approach to their health, recognizing the need for balance in emotional well-being along with keeping their own minds sharp and bodies active. This is driving demand for a range associated with health and wellness products and services. Healthy dwelling now represents a core lifestyle shift. Wellness will be all-pervasive.

What are the particular three core areas identified in elderly healthy living?

BULL CRAP: The three primary areas recognized in seniors healthy living are prevention, nutrition, and lifestyle. Many of the main axis consumers are now looking to deal with their outward appearance. That will is the particular use of anti-aging products and supplements, cosmetic treatments, stylish clothing and accessories, health and wellbeing, that will be illness prevention through self-care plus good nutrition, keeping fit, monitoring your body weight, emotional well-being, and psychological agility. This particular is also seen in populations retiring later: individuals are learning new skills at older ages, volunteering, and ongoing 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 inside the healthful aging sector. At present, claims addressing senior health are very scarce in food and drink launches throughout almost all item categories. Aging populations may open opportunities for health claims within food and drink that are relevant to these consumers, such since cardiovascular, eye, bone, mind, and digestive health.

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40% of US consumers aged 18 in order to 34 agree that preventing disease or even illness motivates them to eat healthily, suggesting that will many younger consumers are already thinking about the particular link among diet plus disease in later existence. However , data from Lightspeed/Mintel reports show that only 50% associated with those older 55 and over are thinking seriously about how nutrition can prevent illness and extend their healthy life term. This is usually a huge opportunity with regard to the FMCG sectors, plus nowhere is definitely this opportunity greater than within the meals and nutraceutical market.

How should nutraceutical companies achieve their maximum potential?

BS: To reach their optimum potential, nutraceutical companies need to tackle three challenges as per research carried out by Mintel. The first of these is to educate healthcare professionals upon nutraceuticals. Consumers are considerably influenced by their particular doctors in terms associated with nutraceutical purchases, but paradoxically, their doctors might have little awareness of them based on their medical education. Investing in practitioner education might forge trust, leading to product recommendations.

Nutraceutical brands should leverage the expertise and trust held in health care professionals’ opinions to support consumer understanding of items, develop resources about nutraceuticals that assistance clinicians’ professional development, plus enhance their scientific work. Evidence-based human research provides the fastest and finest boost in order to this end.

The second pillar can be using nutraceuticals in the particular healthy ageing space. Formulators should invest in the ingredients that are usually proven lifestyle extenders associated with condition reduction and enhancement of cognitive wellbeing.

Prevention plus maintenance associated with current wellness remain strong drivers regarding purchasing nutraceuticals across the lifespan. Nutraceuticals that support healthy ageing and senior consumers’ dietary and nutritional leads may 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 within nutraceuticals.

How are nutraceuticals delivered?

BS: Most nutraceuticals rely on traditional delivery formats, such as tablets, capsules, and powders. Nevertheless , 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 , these people want products that are usually easy to use plus have proven benefits. This particular, coupled with better regulation, which is really important, appropriate marketing to that segment, and validated human clinical evidence, can boost consumer rely upon these items.

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The recent report from Euromonitor highlighted that putting clinical evidence at the forefront helps gain customer trust, plus providing equipment to see benefits is certainly key in order to driving deeper engagement. Examples of this, in recent times, are the particular launch of products along with apps being launched in parallel to the products that allow consumers to track online the efficacy associated with the items for on their own and on by themselves.

Several of these products have been launched in recent years on skin health. They can observe valid, tangible results before their eyes and statement those results online using the app. This example of technology, inside parallel with new item launches, is becoming somewhat of the particular norm.

Though new on the moment, this has the real place in the future: such tech is playing right into the current trend where customers want in order to see outcomes; they want to notice results intended for themselves. Validated clinical evidence is the particular way forward.

How ought to human medical trials take place?

BS: Randomized human scientific trials are considered the gold standard of proof for the scientific substantiation of claims by EFSA as well as the FDA. So RCTs add medical knowledge and provide the effectiveness of interventions to get disease avoidance.

All clinical trials should be conducted making use of good medical practice (GCP). With suitable human subject protections, the particular HSPs, and all products within human testing should be produced below GMP practices using well-established quality administration systems. The particular informed consent process will be 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 conditions of risk management and adhering to GCP throughout the entire process.

What are the differences between foods trials plus pharma tests?

BULL CRAP: Many people are aware of pharmaceutical trials, or drug studies, which have been happening for centuries, but food trials are both run and present differently in terms of the outcome and the particular process. Foods largely look at a health effect, whereas pharma looks at a highly purified and specific disease impact. Foods evaluate a health benefit, while pharma evaluates treatment effectiveness. Food is exploratory, and presently there is a need to incorporate the tested food into the particular normal nutritional backgrounds associated with people within the trials.

They often do not really have pharmacokinetics (PK) or even pharmacodynamic (PD) details available, and they are designed in the free-living environment. The pharma world is explanatory because opposed to exploratory.

In terms of recruitment pertaining to food, these people are smaller populations along with self-described illnesses or near-illness, and in pharma, they will are large populations associated with patients with specific illnesses.

In terms of length and phases, generally, food items have only one phase — a single phase : whereas medicines have a four-phase and can get several years in order to complete, whilst a food trial will take anywhere through months up to a year to complete.

The costs – while arbitrary – very much depend on what is becoming tested. Food trials are much, much lower in cost. A cost for each subject will be generally estimated between $3, 000 in order to $10, 000, very a lot varying upon what is being tested. That will give a person a total cost of somewhere between $100, 000 and $3 million. In the drug world, they are much more expensive. A per-subject price can range between $30, 000 plus $50, 500, and total budgets meant for drug trials run in between $1 million and $50 million, and in some cases, far beyond. They can take years to develop, and while the effect size is a lot more targeted inside drugs, there is a broader general audience in the food space.

In conditions of label claims in both camps: designed for food, the label must be truthful, not misleading, plus based on scientific evidence, according to both EFSA in Europe and the FOOD AND DRUG ADMINISTRATION in the particular US. Within the drug area, information is used as the safety parameter and a description of usefulness as opposed to a truthful statement.

Very best scientific trial procedure?

BS: Lots of tests run within a very similar manner, even though the activities within the test vary massively depending on what the trial is reporting on. The design phase is first, in which usually the protocol is written, the study documentation is usually gathered, rules sense-checked, plus then the ethics process is begun, in which ethics committees oversee almost all trials to make sure that safety parameters just for volunteers are being upheld.

For recruitment, we all recruit the subject database, we conduct the study visits, all of us analyze the results collected, and then we record on the particular results that were analyzed, and that will lead to the good or negative output associated with a trial. In just about all trials, there is typically more compared to one end result. There is definitely a primary outcome, after which there can be several secondary outcomes. In many cases, there would be several exploratory outcomes which will inform long term work or future studies.

What are usually the main singularities around a randomized control trial in elderly populations?

FOR EXAMPLE: Atlantia undertook a study, the main goal of which was in order to assess the efficacy and tolerability of a meals ingredient inside older grownups at risk of acute respiratory tract infections during the winter season. The research population comprised 600 old adults, so we recruited subjects more than 65 yrs with a good increased danger of seasonal ARTIs.

The population reflected the common population associated with older adults, and we ensured that adequate representation of subgroups who had an increased risk associated with ARTIs. These factors included age, dietary status, former and existing smoking status, and certain comorbidities, which usually included frailty, asthma, plus COPD.

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During the screening process, an exhaustive list of exclusion criteria was used, which was determined to make sure the sample represented the general population and also was utilized to maximize the research compliance. This study was a multicenter randomized, double-blind placebo-controlled parallel study. The particular study involved the participants coming within for four visits over 10 months.

The population was separated 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 an one-to-one basis.

What else was relevant inside the study?

The study furthermore took into account the particular subjects’ intention to become vaccinated or even being vaccinated, malnourished or risk associated with malnutrition cohorts, respiratory diseases, which included COPD and asthma, and also the various age cohorts, so sixty-five to 69 years, seventy to 74 years, 75 to 79 years, plus 80 to 84 years, and also 85+ was examined.

The randomization was carried out using an interactive web response system, and this used the minimization protocol. The minimization randomization can be a method of randomization that allocates subjects in to treatment organizations that best maintain balance in prognostic factors. It is effective even in small test sizes and with multiple prognostic variables.

Apart from the information points collected during the visits, a good app was also developed. This app was used to collect data points continuously throughout the particular study. This was a daily diary, which these subjects used in order to record info. This incorporated information about the consumption of their product, any adverse events that they might have had between visits, any medications that they would’ve utilized, and any kind of doctor visits. It has been also used to track whether a subject had an ARTI, plus this was done using the Jackson questionnaire.

If a subject fulfilled certain criteria on the Jackson questionnaire, they were instructed to complete the Wisconsin 24 and record their own temperature. This particular was done until they will recovered from the ARTI symptoms. If the subject recorded which they experienced an ARTI, the site was alerted via the application, and this led to a home visit, that was organized simply by Atlantia or the partner site, and a healthcare professional was sent out to the subject to confirm the particular diagnosis associated with the ARTI, and also to carry out particular procedures in the case of a positive diagnosis.

Within Atlantia, 350 participants had been recruited, plus 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 in order to treat populations, approximately 200 per group were analyzed, and not really all of them were allocated to the per-protocol group. The data analysis is still being performed at the particular moment, so the results are not yet available.

What do you think should end up being the primary takeaways in this area?

BULL CRAP: Population ageing seems inevitable. Companies targeting this very profitable segment might end up being able to get into a competitive advantage position fairly quickly. Disease prevention via nutrition is certainly at the center of healthy lifestyle. However, some challenges still need in order to be overcome, as we all spoke about, when it comes to healthcare professionals’ schooling, format innovation, and trust in the nutraceutical market.

Medical trials seem to be an initiative that supports these 3 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 associated with new methods and technologies coming upon stream, yet also from the interactions among those as well as the study people.

In the particular case of elderly populations, recruitment processes need to be adapted, a combination of clinic visits and home appointments have to be employed, especially for those participants along with reduced mobility, and the development of particular study technologies, such since apps, that will align with the characteristics of the population plus their requirements. The apps we used were simplified, were smartphone-enabled, and took a very short amount associated with time out of volunteers’ daily ongoings.

About Atlantia Scientific Trials

Atlantia Clinical Studies Ltd is a CRO that specializes in conducting studies on meals, beverages, and supplements for the purpose of companies globally that want in order to scientifically validate their practical ingredients to support a good: EFSA (European Food Safety Authority) Health Claim; FDA (Food & Drug Administration) Structure Function Claim; or even General Product Marketing Claim.

Atlantia works with world-leading scientists (among the top cited 1% internationally, within the areas of digestive health plus functional foods) in the: APC Microbiome Institute in University College Cork, Ireland; Teagasc, Moorepark, Ireland, and recognized centers associated with excellence globally.

Atlantia runs and operates its own medical center sites and conducts most studies in order to ICH-GCP regular (International Council for Harmonization of Technical Requirements for Pharmaceuticals with regard to Human Use – Good Clinical Practice). Its team includes physician experts within our digestive health, mental health (psychological stress plus cognition), cardiovascular health, sports performance, metabolic disease, bone health, immune health, and healthy ageing. The clinical team also includes project managers, analysis nurses, nutritionists, certified sports activities trainers plus lab researchers.

Atlantia manages all elements from process design, placebo manufacture, recruitment, and research execution, to sample and data analysis, statistics, plus report/dossier preparation to provide a service that is technically, scientifically, and clinically superior.

The medical studies cover a broad spectrum of useful as well as beverage categories, such as dairy, cereal, probiotics, different protein forms, infant-specific foods, vitamins/minerals, plant or marine extracts, and healthcare foods.

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