18-55 Cognitive Health Users

The younger cognitive health users look for benefits that will allow them to perform their best at task. This consumer group includes college students, professionals, and athletes looking to enhance their cognitive abilities to perform better academically, professionally, or athletically. The benefits this group seeks include energy boost for studying for a college exam, enhanced focus at an important meeting, or increased reaction time for competitive sports. This group of users is more conscious about science-backed ingredients and their benefits, as well as natural or plant-based supplements. They look for products that meet their specific cognitive health needs, have positive reviews from similar users, and have research-backed benefits.

55+ Cognitive Health Users

The aging cognitive health consumer is defined as those that are 55+ and are looking for supplements to improve their cognitive function, memory, focus, and overall brain health. This group of consumers includes seniors, active nutrition retirees, and individuals experiencing age-related cognitive decline. This population tends to buy products focusing on age-related benefits or preventative measures to protect their cognitive abilities as they age. They are also attracted to products with benefits that can help slow down cognitive decline. This group looks for products specifically formulated for their age that are scientifically-backed and include products with crossover benefits that meet their nutritional needs.

Crossover Categories

More recently, as the cognitive health category continues to explode, crossover benefits which include mood, stress, and sleep, are being incorporated into brain health products. Supplement manufacturers are incorporating mood-enhancing and stress-reducing ingredients into cognitive health formulations to represent a more dual mechanistic approach to this category. Another category that includes cognitive health ingredients in their formulation is sports nutrition. As the sports nutrition category continues to innovate its pre-and post-workout products, cognitive ingredients for enhanced focus, energy, and reaction time are included in formulations. These consumers look for these cognitive health benefits for more productive workouts and to get a competitive edge on the field.

Biofortis Clinical Studies

Biofortis offers recruitment and screening of participants with various demographics, including pediatric to elderly and healthy to multiple levels of cognitive impairment. Biofortis’ expertise with testing domain pre-and post-dose product consumption includes a wide range of cognitive health areas. These testing domains have short-term recognition memory, attention, thinking speed, mood, reasoning, reaction time, concentration, and planning.

Biofortis is dedicated to protecting consumers’ health and wellness by delivering a wide range of clinical services for the food, supplement, and nutrition industries.  With over 400 completed studies and 15 years of experience, Biofortis has a leading clinical research team focusing on developing innovative new ingredients, foods, dietary supplements, and nutrition programs.

At the forefront of its offerings, Biofortis’ clinical research provides its clients with dependable science with exceptional on-time budget track records.  The company’s team of experienced scientific and dedicated project managers guide clients through the entire research process.  The robust subject database has more than 20,000 research-integrated subjects for rapid recruitment and an advanced research facility where execution of clinical trials is the company’s top priority.

^[1] Grandview Research Brain Health Supplements Market Size, Share & Trends Analysis Report By Product (Natural Molecules, Vitamins & Minerals), By Application (Memory Enhancement, Attention & Focus), By Region, And Segment Forecasts, 2023 – 2030

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Bodybuilders & Athletes

The sports nutrition category became more defined with the emergence of bodybuilders in the 1960s and 1970s. At that time, sports nutrition products consisted mainly of protein powders and amino acid supplements to enhance performance and improve physique.  Bodybuilders popularized the use of protein supplements such as whey and soy protein and helped hype the use of creatine to enhance strength and power. Athletes, similarly to bodybuilders, wanted to achieve enhanced performance and improved physique to put their best foot forward during game day.

Both bodybuilders and athletes pay close attention to their macronutrient and micronutrient intake to help achieve their goals of building muscle mass, increasing strength, and improving recovery. In regard to supplementation, these two groups look for ingredients such as protein to support muscle growth and repair: amino acids, specifically, branched chain amino acids (BCAA) to help promote muscle protein synthesis and reduce muscle breakdown and creatine to increase muscular strength, power, and endurance. Supplements containing caffeine, beta-alanine, and nitric oxide boosters are also popular within these groups to help enhance energy, muscle pump, focus, and performance during workouts. Bodybuilders and athletes that train extremely hard look for products with enhanced recovery benefits including carbohydrates and electrolytes to replenish glycogen stores and support hydration.

Active Nutrition Users

Active nutrition users are those who participate in regular physical activity such as competitive sports and group workout classes or are individuals who are simply trying to maintain a healthy lifestyle. Active nutrition users consume a variety of dietary supplements to meet their specific fitness goals, including protein powders and bars, amino acid supplements, energy drinks, pre-workout supplements, post-workout supplements, and other sports related products.  These users may also consume nutritional products that support their overall health and wellness such as multivitamins, immune-health boosting products, and probiotics.

Active nutrition users seek products with unique delivery forms including beverages, gummies, gels, and functional foods.  As the active nutrition user population grows and product demands increase, more emphasis is being put on clinically-studied ingredients with science backed benefits. In addition, unique formulations that include plant-based, non-GMO, gluten-free, and natural ingredients are becoming more popular in the mainstream market.

Biofortis’ Clinical Studies

Biofortis offers recruitment and screening of participants with various levels of physical performance from sedentary adults to highly-trained athletes. In-house assessment of exercise performance endpoints test products that may influences a person’s strength, endurance, hydration, energy expenditure, and cardiovascular fitness. Biofortis partners with external labs and experts for related measurements of biological specimens before and after an exercise challenge or program.

Biofortis is dedicated to protecting consumers’ health and wellness by delivering a wide range of clinical services for the food, supplement, and nutrition industries.  With over 400 completed studies and 15 years of experience, Biofortis has a leading clinical research team focusing on the development of innovative new ingredients, foods, dietary supplements, and nutrition programs.

On the forefront of its offerings, Biofortis’ clinical research provides its clients with dependable science with exceptional on-time budget track records.  The company’s team of experienced scientific and dedicated project managers guide clients through the entire research process.  The robust subject database has more than 20,000 research-integrated subjects for rapid recruitment as well as an advanced research facility where execution of clinical trials is the company’s top priority.

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The immune system is influenced by many modifiable and unmodifiable factors, such as genes, age, sex, stress, hormone, exercise, drinking, smoking, health condition, and nutrition status. The significance of nutrition in the robust, optimal immune system is manifested especially during malnutrition, including undernutrition and overnutrition because an optimal supply of nutrients is required for the biosynthesis of immune factors and immune cell proliferation.

Nutrient inadequacies/deficiencies can increase the risk of infectious diseases and aggravate consequent symptom severity and complications if infected. Therefore, an adequate and balanced diet containing an abundant diversity of foods, nutrients, and non-nutrient chemicals is paramount for an optimal immune defense against infectious diseases, including cold/flu and non-communicable diseases. Micronutrients, including vitamins A, C, D, B6, B9, and B12, copper, iron, selenium, and zinc, as well as dietary fibers and non-nutrient phytochemicals, such as polyphenolics, collectively function to support the development and maintenance of the immune system and are being considered an immunostimulant. Additionally, the abundance of protein in the diet is essential for immunity as it is required for the proliferation of immune cells.

Optimizing Oat Nutrients

Recently, we published a review discussing the contribution of oat nutrients including dietary fiber (β-glucans), copper, iron, selenium, and zinc, polyphenolics (ferulic acid and avenanthramides), and proteins (glutamine) to optimizing the immune system’s response to infections. Oats are a renowned source of dietary fibers and β-glucans. While these molecules may directly modulate the immune system, they can also improve/maintain immunity through indirect mechanisms, such as modifying the gut microbiota composition and functions and increasing the production of SCFAs. Polyphenolics, including ferulic acid and avenanthramides in oats, can help optimize the immune system by regulating inflammatory response, boosting the antioxidant defense system, and modulating the gut microbiota.

Glutamine, an amino acid known for reducing infectious complications, also supports the consumption of oats for maintaining the pool of glutamine for immunity support. The information discussed in the review is significant particularly during the global SARS-CoV-2 (COVID-19) pandemic as people are more likely to consume energy dense food high in fats, refined carbohydrates, and sodium, which collectively impair the immune system and host defense against infection.

Further Reading

https://www.mdpi.com/2072-6643/13/4/1048

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Where did I leave my keys?

I’m sorry, what’s your name again?

I can’t remember if I should turn left or right.

What did I come in here for?

Sound familiar? We’ve all misplaced keys, forgot someone’s name, have difficulties recalling directions, or entered the kitchen and blanked on why you went there in the first place. Memory lapses are frustrating, but they happen and are not usually concerning. As we age, memory lapses happen more often and it is part of healthy aging. However, when memory loss becomes persistent and affects your ability to function, it becomes worrisome. According to a recent market analysis, the global brain health supplements market size is expected to reach USD 13.38 billion by 2028. Of the different types of brain-boosting supplements, those for memory enhancement dominated the market in 2020, with more than 25.0% revenue share, likely driven by the growing aging population.

Recently, we conducted and published an investigation into the effects of citicoline (Cognizin®), a naturally occurring mononucleotide, on memory in 100 healthy elderly adults with age-associated memory impairment. After daily consumption of 500 mg of a commercially available citicoline supplement for 12 weeks, we observed that citicoline supplementation improved composite memory, specifically episodic memory, when compared to the group taking placebo. Episodic memory describes the ability to remember and recall specific events, paired with the content in which they occurred, such as identifying when and where an object was encountered. A decline in episodic memory often manifests as the inability to recall past events or retrieve lessons from past experiences which can lead to repeat error and has been shown to decline with aging. Our results are consistent with other clinical trials that have shown improvements in memory following citicoline supplementation in older men and women, without eliciting any serious adverse events. Our findings suggest that regular consumption of Cognizin® may be safe and potentially beneficial against memory loss due to aging.

Check out our paper to learn more about the study here.

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Dr. Beckman began working at Biofortis in January of 2020. She finds participating in clinical research interesting because during her training, she read about studies all the time in journal publications. Beckman graduated from University of St. Francis in Joliet, and then went on to Loyola University Chicago – Stritch School of Medicine. She then completed her fellowship at Northwestern University.

Dawn wears many hats at Biofortis, but mainly she is in charge of making sure studies are safe for subjects.

“If [subjects] are having any symptoms, side effects or diagnoses, they get evaluated to see if it could potentially be related to something in the study that they’re taking or doing, or if it is something potentially pre-existing,” said Dawn. “We’re always looking out for the safety of the subjects.”

Dr. Beckman has loved her job at Biofortis since day one, because her colleagues are so enthusiastic and motivated, and for the most part, her subjects are healthy and happy to be there. She said this is a nice juxtaposition from her other office, a private practice where she specializes in Allergy and Immunology, where most patients come to her with complaints or issues.

Outside of work, Dawn enjoys various hobbies. She loves to garden, and this year she is attempting to grow pumpkins. She not only knits, but also designs knitwear, by taking patterns and making them her own. Dawn also enjoys DIY home improvement projects. Growing up, her father was a handyman around the house, and being the oldest daughter, she would help him and learn from him. When she is not working at Biofortis or her private practice, you might find her doing one of these creative projects.

Biofortis is a full service clinical research and scientific consulting company. Our research is focused on foods, ingredients and dietary supplements. Research conducted at Biofortis has helped evaluate food and nutrient metabolism and tolerance, support label claims, and demonstrate health benefits of products in the general and specific populations.

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I have always been a huge foodie, and a few years ago I started a food blog on Instagram called @llizagna. I photograph and post pictures of food that look amazing, and in the captions I let my followers know how they tasted and if I would recommend them. Something I have learned from running this account is that food can look really appetizing and aesthetically pleasing, but if it tastes bad, no one will eat it. The opposite is true as well. Food can be really tasty, but if it looks gross, consumers will not buy it.

Last summer, I worked as a marketing intern at Biofortis Research, a division of Merieux NutriSciences in Addison, IL. Before my internship, I did not realize how much work goes into making products both look and taste appetizing. Biofortis helps companies fine-tune their products in both of these aspects. The Addison location has a Sensory and Consumer Insights department where they are contracted by food companies to conduct studies on their products to make sure they are accepted and presented to the best of their ability. Biofortis recruits everyday consumers and trains professional taste testers to test and review products. With the testers’ feedback, the sensory scientists of Biofortis/Merieux systematically evaluate and present the products’ scores and acceptability to the sponsoring companies.

Clinical Trials & Scientific Consulting

The other department at Biofortis is the Clinical Trials and Scientific Consulting division. This group conducts clinical trials, manages the data, publishes manuscripts and much more. Companies hire Biofortis to conduct studies that often support marketing claims, such as “lowers cholesterol” or “aids weight loss.” Recently, Biofortis provided the scientific report used in an FDA-approved qualified health claim submitted on behalf of Ocean Spray Cranberries, Inc., which states that consuming cranberry products can lower the risk of recurrent urinary tract infections.

Biofortis’ two departments go hand-in-hand and support the point I stated earlier. Consumers might be interested in a product because of the beneficial health claims on its label, but if it looks or tastes bad, no one will want it. Again, the opposite is true as well. Something could look and taste great, but a consumer might choose an alternate product that has beneficial health claims. There is so much that goes into understanding what a consumer looks for in their products. I have taken what I learned at Biofortis and applied it to my food blog. Now, I make sure to discuss not only a food’s taste and appearance, but its health benefits (or lack thereof) as well. Biofortis has shown me that there is so much that goes into perfecting a product, and it comes down to understanding what consumers want.

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COVID-19 Safety Precautions at Biofortis

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Biofortis Clinical Research site in Addison remains open for both clinical visits and consumer testing.

As the COVID-19 situation continues to evolve, Biofortis and its parent company, Mérieux NutriSciences, are taking action both for the safety of our employees and to help protect our subjects and our larger community.

Our priority is to create as low risk an environment as possible for our staff and for our subjects in order to help minimize the potential spread of the virus.

Biofortis Clinical Guidelines for COVID-19

In accordance with federal and state recommendations.

All People Entering the Building

• Must complete a brief health questionnaire upon entrance and those recording relevant risk factors are refused admittance
• Will have gloves, masks, hand washing stations, tissues, and sanitizer available to them
• Are requested to cough and sneeze into their elbow or a tissue and immediately wash hands after and sanitize
• Are encouraged to avoid touching their face as much as possible
• Must not enter the building if feeling ill but call to reschedule the appointment

Cleaning and Infection Control Measures

• Areas utilized by staff and/or subjects are frequently sanitized after use on all surfaces including, but not limited to, chairs, tables, keyboards, pens, etc. . .
• A cleaning and sanitizing schedule is implemented daily
• Sanitation solution is available for all employees throughout the building for sanitation use
• Maintain the practice of good hygiene by all staff including frequent hand washing
• Staff must wear face coverings
• Social distancing will be maintained whenever possible

Ongoing Clinic Study Visits

• In-person visits are modified to limit contact as much as possible and vary based on study requirements
• Curbside pickup when able will be utilized for product dispensation
• Study materials are sanitized in between each use during visits

Sensory Testing

• When able, descriptive and consumer studies have moved to curbside pickup with samples being placed directly in the panelist trunk.
• In lab testing parameters have been implicated:
  • Extra 5 minutes in between sessions to thoroughly clean the booth area in between sessions, which includes the computers, mice, keyboards, walls, chairs, etc.
  • Limit the number of consumers per session to every other booth testing.
  • Even before the pandemic, our sensory staff was trained to handle and serve food safely. This includes but not limited to: wearing gloves and changing them as often as needed, cleaning and sanitizing all work surfaces, and avoid being in the kitchen when ill.

As the situation rapidly evolves, our Global MXNS task force continues to monitor the situation and provide updated guidance and, if necessary, updated restrictions. Biofortis will implement the updated restrictions immediately.

Please feel to reach out to us with any additional questions you may have.

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• New methods to collect clinical trial data, especially in view of the COVID-19 pandemic, should be considered
• Faster and potentially more accurate data collection
• Benefits and limitations of mobile app technology in clinical trials

The potential for mobile technology in improving clinical trials is being increasingly recognized by sponsors and researchers.  For several years, the Food & Drug Administration (FDA) has been encouraging the use of mobile technologies to enable faster, more cost-effective clinical trials (1). With the concerns of the safety of in-person clinical visits during the COVID-19 pandemic, mobile platforms for remote data collection as well as remote data audits might be a solution for clinical trials now and in the future.

Benefits of Utilizing Mobile Apps in Clinical Research

Enhanced Safety

Top of mind now is the safety of study subjects and staff. On March 18, FDA just released its guidance (2) on the safety of conducting clinical trials during this pandemic. If it is not possible for the study subjects, staff, or monitors to be safely present at the research facility, alternative methods for study visits, such as virtual study visits, may be a solution.  Virtual visits (both for the study subjects as well as the monitors) will include electronic tools to capture data. Overall, the FDA is granting clinical research sites flexibility to consider remote visits and electronic data capture to ensure the safety of all involved.

Improved accuracy

Data collection in real-time reduces errors and improves efficiency because the information is transferred directly from the subject in real-time to an electronic data capturing (EDC) system. These include responses collected using wearables such as Apple Watch, Android Watch, FitBit, and other activity or diet trackers, or patient-reported outcomes from customized surveys.  The EDC can also be programmed to detect errors and prompt the participant to correct the error before moving forward.  Researchers can also monitor the results in real-time, thus allowing for timely corrective actions.

Real life in real time

App-based clinical studies can take advantage of the latest in mobile technology to collect real-world data in real-time, such as on physical activity, heart rate, sleeping patterns, food intake, and social interactions without the confounding factors introduced by an artificial clinical trial setting. Mobile apps may also be configured to send out customized notifications for any event or response entered in a study – an especially helpful feature for rapid visibility on adverse events. This indirectly makes a study safer for participants and allows for better outcomes.

Borderless E-studies

Mobile technology not only revolutionizes the way data is collected and monitored but allows for more expansive studies with less subject burden.  Omnipresent mobile apps enable larger, multi-site studies with unlimited geographic boundaries and subject diversity. Indeed, since 2014, the number of active mobile devices has outnumbered the world population (3). Virtual, app-based recruitment, test visits, and follow-up appointments reduce the need for physical site visits and saving time for both researchers and participants.  More than 75% of US adults surveyed expressed a preference for joining a mobile trial compared to only 7% for a traditional trial (4), suggesting the potential for faster recruitment and better retention in trials utilizing mobile technologies.

The Future of Mobile Technology and Clinical Research

Mobile technology has the potential to make clinical trial participation more safe and convenient for participants as well as help researchers improve operational performance and potentially reduce the risk of clinical trial deficiencies.  However, the implementation of mobile apps in clinical research requires an understanding of its potential limitations and challenges.  These include concerns on data security and resistance from participants such as those with limited experience with technology (e.g., the elderly).  Despite the benefits of mobile apps, some trials are better conducted in a traditional, non-mobile-based setting.  Thus, companies interested in using mobile apps in clinical trials are urged to seek out experienced research organizations to ensure the successful implementation of mobile technologies in their trials.

As a leading contract research organization, Biofortis Research, a division of Mérieux NutriSciences, has been successfully utilizing mobile technology in clinical trials.  Biofortis offers full clinical trial services from protocol design, recruitment, trial executive, data collection, and analysis to writing reports and publications to assist customers who are interested in conducting clinical trials with or without mobile technology.

References:

(1) FDA. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-launches-new-digital-tool-help-capture-real-world-data-patients-help-inform-regulatory-0

(2) FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

(3) Independent. https://www.independent.co.uk/life-style/gadgets-and-tech/news/there-are-officially-more-mobile-devices-than-people-in-the-world-9780518.html

(4) Perry B, Geoghegan C, Lin L, McGuire FH, Nido V, Grabert B, Morin SL, Hallinan ZP, Corneli A. Patient preferences for using mobile technologies in clinical trials. Contemp Clin Trials Commun. 2019;15:100399.

Author Bios

Valerie Wass, RDN, LDN

Val has worked for Biofortis Research in Addison, IL for 10 months as a Clinical Research Coordinator and she is also a Registered Dietitian. Prior to Biofortis Research, Val worked as a registered dietitian focusing on weight loss nutrition counseling and as a corporate dietitian for a food service management company. In her spare time, Val enjoys cooking, walking her black Labrador, and hiking in the mountains.

Claire Dillon, RD, LDN

Claire has been with Merieux NutriSciences for 2 years in various roles and now is a Clinical Research Coordinator with Biofortis Clinical Research. Claire is a Registered Dietitian with experience in clinical and long-term care settings. In her free time, she enjoys relaxing with her cats and trying out the newest restaurant in town with her friends.

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