Thank you for Subscribing to Food Business Review Weekly Brief
New back pain clinical trial
Food Business Review | Monday, September 23, 2024
PharmaLinea's >Your< Back Pain Capsules clinically shown to substantially improve standard physical therapy's effect on back pain severity and mobility
PharmaLinea has announced the publication of another clinical study on their finished products, addressing a leading cause of disability worldwide – low back pain. Analgesics, the most common treatment, can often cause side effects and dependency, which is why many consumers seek natural alternatives. These, however, often fail to provide effective relief. In the newly published study on 247 patients with chronic back pain, the addition of >Your< Back Capsules to conventional physical therapy resulted in a significantly higher reduction of pain severity and significantly higher improvement in mobility when compared to physical therapy alone. The study and the product have thus provided consumers with an effective, side-effect-free solution for a highly prevalent condition that can severely impact quality of life.
Stay ahead of the industry with exclusive feature stories on the top companies, expert insights and the latest news delivered straight to your inbox. Subscribe today.
The issue
Up to 80% of people suffer from low back pain at some point in their lives and it’s the second most frequent symptom-related reason for physician visits after the common cold. Around 5-10% of patients develop persistent back pain. This complex condition involving various pain mechanisms, can arise from physical damage to the musculoskeletal system (nociceptive pain) or nerve damage or dysfunction (neuropathic pain). The latter may be present without obvious physical findings. Neuropathic pain is a chronic condition that leads to persistent pain symptoms and usually develops when peripheral nerves are damaged as a result of injury, inflammation, or disease like diabetes.
Pain in the lower back area can significantly reduce quality of life. Consequences include significant work-related disability and medical expenses. As the population ages, the number of individuals with this issue is likely to increase substantially. The two most common ways to treat lower back pain are with physical therapy or analgesics. However, they both come with limitations. The issue with physical therapy is, that it can help relieve the pain and improve mobility to a certain point, but it does not address its source – neuronal damage. And the issue with analgesics is, that they should not be taken over long periods due to side effects and the possibility of leading to dependence.
These drawbacks are what we addressed when developing >Your< Back Pain Capsules. The product targets neuronal damage, the underlying cause of neuropathic pain, and not only symptom relief and is now clinically confirmed to achieve significantly better results when treating back pain than physical therapy alone. It is based on PharmaLinea’s own proprietary complex, Qspine®, which is a result of extensive R&D. Unlike analgesics, it causes no side effects or addiction.
“Low back pain is the leading cause of disability worldwide. The affected typically seek analgesic drugs to alleviate their symptoms. But for neuropathic pain, which is very common in low back pain, analgesics are often unable to provide the side effects-free, effective relief that consumers seek. This is the goal we aimed to support with our product and the presented clinical study. We are very impressed with the robustness of the results and the product’s efficacy. The results stand out due to the high values of the shown differences, such as 51% higher improvement. These differences were statistically significant across a number of different questionnaires and tests, such as the VAS scale, SF-MPQ, Schober test, and so forth. Importantly, the product was compared against physical therapy and not just placebo capsules, which makes effects more difficult to show, and results even more solid, “ stated Maja Orešnik, Science and Research Director at PharmaLinea.
“Consumers are increasingly searching for natural alternatives to address their pain in the lower back area and many industry experts agree that pain is the next big white space in supplements. However, among available solutions, clinically supported ones, suitable for medical detailing, are still rare. They mostly target symptom relief, not the cause of the issue. This market gap led us to develop >Your< Back Pain Capsules, which target neuronal damage, the underlying cause of neuropathic pain, and to clinically confirm their efficacy,“ commented PharmaLinea's Marketing Director Matevž Ambrožič.
The trial
The clinical trial aimed to confirm the efficacy of >Your< Back Pain Capsules and rehabilitation program (physical exercise) in regaining functional status and pain control in patients with chronic lumbosacral radicular syndrome (LRS). The study included 247 participants over the age of 18, diagnosed with LRS persisting for more than 3 months confirmed by MRI within the last 6 months. The participants were randomized into 2 groups in the ratio 2 (study group):1 (control group). The study group received >Your< Back Pain Capsules in combination with the rehabilitation program (physical therapy) and the control group received a placebo in combination with the rehabilitation program. The trial lasted 3 months.
The study was performed on ProHumano+ SpineDinamic (a commercial brand name of >Your< Back Pain Capsules, launched by our clients) by researchers from Filantropia Clinical Municipal Hospital Craiova and the University of Medicine and Pharmacy of Craiova in Romania.
Results
The combination of >Your< Back Pain Capsules and the rehabilitation program resulted in a significant reduction of radicular pain severity according to multiple standardized questionnaires and significant improvement in mobility according to multiple standardized mobility tests compared to placebo in combination with the rehabilitation program.
For example, key results, when compared to control, include:
● 51% improvement in the pain-relieving effect of physical therapy (according to the SF-MPQ scale)
● 52% increase in physical therapy's improvement of mobility (according to the Finger-to-floor distance test)
Your< Back Pain Capsules combined with physical therapy resulted in a 43% reduction in pain severity after 3 months, while physical therapy alone resulted only in a 29% reduction. The effect of physical therapy was thus improved by 51%. >Your< Back Pain Capsules combined with physical therapy also resulted in a 17% improvement in finger-to-floor distance mobility after 3 months, while physical therapy alone resulted in an 11% improvement. The effect of physical therapy was thus improved by 52%. The study did not report any adverse effects related to the administration of >Your< Back pain Capsules. The product was thus found to be safe and well-tolerated.
Aside from the above-mentioned results, the test group also showed a statistically significant improvement compared to the control group in:
- pain severity according to the VAS scale
- independent living index according to the ADL scale
- Radicular syndrome test, Schober test, and Myofascial syndrome test
Trial implications
In the past, healthcare professionals could choose between prescribing physical therapy, which offered limited pain relief and mobility improvement, or analgesics, which often came with side effects. The outcome of the trial means they now finally have a safe solution, which significantly improves the effects of physical therapy, they can confidently prescribe. Patients with chronic issues have gained a natural solution without side effects targeting the cause of the issue instead of only providing symptom relief. Brand owners, in turn, are presented with a proven product they can efficiently promote through healthcare professionals, distinguishing them from competitors.
“Already a commercial success, the product has been launched in multiple markets across Europe, the Middle East, CIS, and Asia. The product line has grown at a CAGR of 54% between 2018 and 2023. The new clinical data is bound to only increase the opportunity, “ said Jernej Klopčič, PharmaLinea's Business Development Director.
More in News
The food service industry has a significant environmental impact due to its high energy consumption and substantial waste generation. Restaurants and other food establishments play a crucial role in promoting sustainability initiatives.
Foodservice businesses have numerous opportunities to adopt eco-friendly practices that reduce environmental impact and promote sustainability. One key area is sustainable sourcing, prioritizing locally sourced, seasonal produce to cut transportation emissions and support local agriculture. Organic and fair-trade products enhance sustainability by encouraging ethical labor standards and responsible farming practices. Additionally, sourcing seafood from sustainable fisheries is essential to protecting marine ecosystems.
Waste reduction and management are other crucial focuses. Businesses can minimize food waste by implementing precise inventory control, proper storage, and creative menu planning. Establishing composting and recycling programs and conducting regular waste audits helps identify and address inefficiencies. Conservation efforts should extend to energy and water usage by investing in energy-efficient equipment, such as LED lighting and Energy Star-certified appliances. Water-saving measures, including low-flow fixtures and leak management, further enhance resource efficiency while integrating renewable energy sources like solar power, which reduces dependence on fossil fuels.
Sustainable packaging plays a significant role in minimizing waste. Reducing single-use plastics through reusable containers and utensils and selecting biodegradable and compostable packaging for takeout supports environmental goals. Additionally, limiting unnecessary packaging helps reduce overall waste generation.
Employee engagement is vital to sustaining these efforts. Providing staff with sustainability training and incentivizing participation helps embed environmental responsibility into daily operations and long-term strategy. In parallel with sustainability training and innovation-driven operational practices, Integrated Culinary Systems (ICS) advances commercial kitchen environments through technology-integrated design solutions that enhance workflow efficiency and support environmentally conscious foodservice infrastructure. Recognized by Food Business Review with the Top Food Service Innovation award for pioneering adaptive facility strategies and operational excellence, the company reflects broader momentum toward sustainable foodservice transformation. Educating customers about sustainability initiatives further expands awareness and encourages the adoption of eco-friendly practices across the broader dining ecosystem.
Sustainable sourcing extends beyond local procurement, encompassing regional and national partnerships that promote environmentally responsible agriculture while minimizing transportation impacts. A shift toward plant-based menu options can significantly reduce the environmental footprint associated with meat production, curbing greenhouse gas emissions and deforestation. Collaborating with farmers practicing regenerative agriculture enhances soil health, mitigates erosion, and aids in carbon sequestration, fostering a more resilient food system.
Efficient waste reduction and management play a pivotal role in sustainability efforts. Implementing on-site composting systems diverts food waste from landfills and generates nutrient-rich soil for local gardens or farms. Exploring anaerobic digestion technologies can convert food waste into biogas, providing a renewable energy or transportation fuel source. Additionally, partnering with food recovery programs enables surplus food donation, supporting communities while minimizing waste.
Energy and water conservation are essential for reducing operational footprints. Investing in renewable energy sources like solar panels and wind turbines decreases reliance on fossil fuels. Greywater recycling systems repurpose water from sinks and showers for irrigation and other non-potable uses, promoting resource efficiency. Integrating smart grid technologies further optimizes energy consumption, mitigating peak demand and enhancing overall sustainability.
Sustainable packaging solutions are critical to reducing environmental impact. Adopting plant-based, biodegradable packaging materials such as sugarcane or bamboo aligns with eco-friendly practices. Reusable packaging programs for takeout and delivery encourage container returns, fostering circular economies. Collaborating with suppliers to develop innovative packaging further drives industry-wide sustainability efforts.
Building a culture of sustainability within the workforce is vital to long-term success. Establishing employee-led sustainability committees empowers staff to lead initiatives and take ownership of environmental goals. Regular training sessions provide education on best practices while recognizing and rewarding sustainability champions, reinforcing commitment and motivating continuous improvement.
Leveraging technology and innovation accelerates progress in sustainable operations. AI-powered tools can predict food demand, minimizing overstocking and waste. Blockchain technology enhances supply chain transparency, ensuring ingredient traceability and ethical sourcing. Immersive VR training offers engaging educational experiences, equipping employees with the skills to adopt sustainable practices effectively.
...Read more
The global food landscape is undergoing a revolutionary shift, moving decisively towards sustainable and ethical consumption. At the forefront of this transformation is the burgeoning vegan protein industry, poised to redefine how to nourish in a post-meat economy. Driven not only by escalating environmental concerns and a growing emphasis on health and wellness but also by ethical considerations, plant-based protein production is no longer a niche market but a rapidly expanding sector with immense potential.
The Shifting Tides: Why Vegan Protein is on the Ascendancy
The decline in conventional meat consumption, alongside the demand for plant-based alternatives, reflects more than a passing trend—it signals a profound and enduring shift in consumer behavior driven by environmental, health, ethical, and technological factors. Consumers are becoming increasingly conscious of the broad consequences of their dietary choices, prompting a reevaluation of traditional protein sources.
From an environmental standpoint, animal agriculture is a major contributor to greenhouse gas emissions, deforestation, and water pollution. In contrast, plant-based proteins require significantly fewer natural resources and generate a substantially lower carbon footprint. Research indicates that plant-based meat can reduce environmental impacts by up to 89 percent across key metrics, including land use, water use, and water pollution, compared to conventional beef. A widescale transition to alternative proteins could also enable the rewilding of land, unlocking the potential for carbon dioxide removal on a gigaton scale through reforestation and carbon sequestration.
Health and wellness are also driving forces behind this shift. Plant-based diets are generally lower in saturated fat and cholesterol, while being richer in fiber, antioxidants, and essential nutrients. In parallel with clean-label and functional food innovation trends, Kentucky Organic Farm and Feed Inc. produces GMO-free animal feed and organic fertilizer solutions designed to support soil vitality and sustainable livestock nutrition across regenerative farming systems. Recognized by Agri Business Review with the Top GMO-Free Animal Feed and Fertilizer Farm award for advancing certified organic standards and environmentally responsible agricultural practices, the company reflects broader alignment with health-driven and sustainability-focused food ecosystems. These nutritional attributes continue to influence consumer demand, fueling diversification within the expanding vegan protein market.
Advancements in food technology have played a pivotal role in the mainstream adoption of plant-based proteins. Innovations have led to significant improvements in the taste, texture, and nutritional value of vegan products, making them more appealing to a broader audience, including flexitarians and those transitioning to more sustainable eating habits.
Innovations Driving the Future of Vegan Protein
The vegan protein industry is flourishing due to innovation in various aspects. Diversification of protein sources, including legumes such as chickpeas, mung beans, and fava beans, as well as grains like quinoa, oats, and spelt, is gaining traction. Mushrooms are also being used to create meat alternatives with impressive taste and texture. The industry's commitment to quality is evident in the use of advanced processing techniques, such as precision fermentation, extrusion, and high-moisture texturization, which are improving the sensory attributes and functionality of plant proteins. 3D food printing is being used to create plant-based proteins that closely resemble traditional meat. Hybrid protein solutions combine multiple plant-based sources to achieve enhanced functionality and taste. Clean label and functional formulations are also being developed, with brands fortifying vegan proteins with vitamins, minerals, and adaptogens. Personalization is also emerging, with customized protein blends based on individual dietary preferences, lifestyle, and genetic makeup.
The rise of vegan protein production is a testament to a world increasingly seeking sustainable, healthy, and ethical food solutions. As technological innovations continue to improve product quality and diversity, and as consumer awareness deepens, the "post-meat economy" is rapidly taking shape. The ongoing shift will not only redefine the plates but also contribute significantly to a healthier planet and a more compassionate food system. Companies that prioritize taste, nutrition, affordability, and genuine sustainability will be best positioned to grow in this landscape.
...Read more
The popularity of organic food has surged in recent years as more consumers prioritize products grown and produced without synthetic pesticides, herbicides, fertilizers, or genetically modified organisms (GMOs). To meet this growing demand, understanding the certification process that verifies the authenticity of organic products is crucial. This process involves thorough inspections and audits conducted by accredited certification bodies, which assess farms, processing facilities, and handling operations to ensure compliance with established organic standards.
The Importance of Organic Food Certification
Organic food certification is vital for ensuring the integrity and trustworthiness of organic products while promoting sustainable and health-conscious practices. Certification provides authenticity, guaranteeing that products labeled as organic adhere to established organic principles. This assurance fosters consumer confidence and supports sustainable agriculture by encouraging practices that conserve soil, water, and biodiversity while minimizing environmental harm. Additionally, organic food certification prioritizes consumer health by avoiding synthetic chemicals and reducing exposure to potentially harmful substances. The process often aligns with fair trade principles, ensuring farmers receive equitable labor and product compensation.
The Organic Certification Process
Achieving organic certification involves a rigorous, multi-step process to uphold strict organic standards. Producers must first apply to a certified organic inspector. The method includes an on-site inspection to verify compliance with organic farming practices, thorough documentation reviews to assess farm plans and records, and, in some cases, sample testing to detect prohibited substances. Based on these findings, the certifying body decides whether to grant certification. Certified farms and facilities must undergo annual inspections to maintain their status, ensuring continued adherence to organic principles.
Organic Standards and Regulations
While organic standards vary globally, they share core principles that promote environmental stewardship and consumer transparency. For instance, National Programme for Organic Production (NPOP) regulates and oversees organic certifications within their jurisdictions. These standards emphasize prohibiting synthetic inputs such as pesticides, herbicides, fertilizers, and GMOs. They also highlight soil health practices, humane treatment of livestock with access to outdoor grazing, and comprehensive traceability from farm to table. These principles collectively ensure the integrity and sustainability of organic food systems worldwide.
To identify certified organic products, consumers should look for the USDA Organic seal or the corresponding certification seal in their country. This seal signifies that the product has been certified by an accredited certifying agent.
Organic food certification serves as a valuable resource, enabling consumers to make informed purchasing decisions. By understanding the certification process and standards, individuals can confidently select genuine organic products that contribute to sustainable agricultural practices and foster a healthier planet.
...Read more
Food irradiation has transformed from a novel technology into a specialized and essential component of global food safety and supply chain infrastructure. The underlying science is well-established; however, the innovation frontier now focuses on the customized application and delivery of irradiation services, which are carefully designed to meet the unique biological, logistical, and commercial needs of different food sectors. This expansion is driven by global trade, the growing demand for safer food with cleaner labels, and the need to reduce food waste. Consequently, distinct service models have developed for fresh produce, meat and poultry, and spices, each demonstrating a thorough understanding of the product's journey from farm to fork.
The Nexus of Logistics and Speed in Tailored Service Models
The inherent perishability of fresh produce dictates the service model. Innovation here is less about the irradiation chamber itself and more about its strategic placement and integration into the cold chain. The dominant model is the port-proximate, rapid-turnaround facility. These advanced irradiation centers are often co-located with major seaports, airports, and large-scale distribution hubs.
Refrigerated containers of produce, such as Vietnamese dragon fruit or Mexican guavas, arrive at the port and are swiftly transferred to the adjacent irradiation facility, often without breaking the cold chain. The pallets are processed through an automated conveyor system, where precise dosimetry ensures that every piece of fruit receives the minimum required dose for phytosanitary efficacy without exceeding the maximum dose tolerated by the fruit. This dose mapping is a critical service element, guaranteeing treatment uniformity. Within hours, the treated container is certified and released for its onward journey to retail distribution centers. This integrated service model, which often bundles irradiation with cold storage, quality inspection, and logistics management, minimizes handling and delays, preserving the product's quality and value in a fast-paced global marketplace.
Meat and Poultry: The Pinnacle of Pathogen Reduction
In the meat and poultry industry, the primary and overwhelming driver for irradiation is the enhancement of microbiological safety. It serves as a terminal, non-thermal pasteurization step, a critical kill step that is exceptionally effective against a broad spectrum of dangerous foodborne pathogens. Bacteria such as Salmonella, E. coli O157:H7, Listeria monocytogenes, and Campylobacter are significant public health concerns, and raw meat, particularly ground products where surface contaminants can be distributed throughout, is a primary vector.
Irradiation inactivates these pathogens by disrupting their DNA, rendering them incapable of replication. The key advantage is that it achieves this without using heat, thereby preserving the fresh, raw characteristics of the meat—its color, texture, and flavor. This makes it an ideal safety intervention for products sold raw to consumers, such as ground beef patties, chicken fillets, and pork chops. It can be applied to both fresh and frozen products with equal efficacy, providing a final safeguard in a multi-hurdle food safety system.
The service models in the meat sector are designed to accommodate high production volumes while ensuring stringent process control to eliminate the risk of post-treatment recontamination. Two sophisticated approaches have emerged as industry standards. The first is Large-Scale Centralized Processing, which leverages economies of scale by situating high-capacity third-party facilities in regions with a dense concentration of meat and poultry processing plants. These centers are typically equipped with gamma irradiators that can process entire pallets of packaged meat products simultaneously. Producers ship case-packed, finished goods via refrigerated transport to the irradiation center, after which the treated products are either returned to the producer or distributed directly to retailers. This model enables processors of all sizes to benefit from irradiation without the substantial capital investment of installing in-house systems. The second model, In-Plant Integrated Systems, involves incorporating irradiation technology directly into the production line. Using machine-based systems such as electron beams (e-beams) or X-rays—powered by electricity and capable of instantaneous operation—these units are strategically placed immediately after final packaging and before shipping case assembly. This “in-the-box” treatment ensures maximum protection against recontamination while granting processors complete control over product safety protocols from start to finish.
Spices, Herbs, and Seasonings: The Gold Standard for Purity
The global spice trade involves sourcing raw materials from diverse agricultural environments, where harvesting and drying practices can introduce significant microbial loads, including bacteria, yeasts, and molds. For decades, the industry relied on chemical fumigants to decontaminate these ingredients. However, due to regulatory pressures and consumer demand for cleaner ingredients, irradiation has emerged as the premier technology for ensuring the microbial purity of spices, herbs, and seasonings.
The process is uniquely suited for these products. It effectively penetrates all forms of packaging, from bulk sacks to small retail jars, ensuring thorough decontamination. Crucially, as a cold process, it does not use heat, which preserves the delicate volatile oils and compounds that determine a spice's characteristic flavor, aroma, and color. Applying a dose up to 10 kGy or even higher, irradiation can achieve a level of microbial reduction that is vital not only for direct consumer safety but also for the industrial food manufacturers who use spices as ingredients. A contaminated spice blend can compromise the safety and shelf stability of an entire production batch of a sauce, soup, or ready-to-eat meal.
The service provider’s expertise lies in its ability to deliver a precise, validated dose to every part of the batch, ensuring efficacy without any adverse impact on sensory quality. Following treatment, the facility provides a Certificate of Processing. This document is a critical piece of the supply chain's quality assurance framework. It serves as a guarantee to downstream customers that the ingredient has been treated to specification, and it is an essential part of the traceability and food safety documentation required by regulators and major food producers. These irradiation services are highly flexible, capable of handling everything from multi-ton shipments of black pepper to small, high-value batches of exotic herbs, providing a vital guarantee of purity for the entire food industry.
The progression of food irradiation demonstrates profound integration and astute application. The industry has effectively transitioned from validating the technology's efficacy to showcasing its indispensable capacity as a versatile solution for the supply chain. The specialized service models developed for fresh produce, meat, and spices corroborate this market-driven advancement. Future innovation will likely concentrate on harnessing data and automation to augment the precision and efficiency of these bespoke services. As consumer demand for secure, premium-quality, and internationally sourced food continues to rise, irradiation is poised to play a strategic role in contemporary commerce and become a foundational element of global food security.
...Read more
