- Clinical trials -
Capture evidence that your product reduces psychological stress from both acute and chronic sources.
clinical trials for stress relief
The global stress management market is expected to top $20 billion by 2024. Clinical research gives your stress reducing product a competitive advantage.
Products capable of either reducing stress-related symptoms or improving the body's ability to respond to psychological stress deliver improved quality of life, enhanced productivity, and higher quality emotional health, resulting in a substantial market for natural supplements. With more and more consumers expecting scientific substantiation for marketing promises made, clinical trials on stress-management products are now a must.
Findings from a clinical trial unlock numerous new avenues for marketing, brand integrity, and even stability. These findings allow you to legally and ethically make marketing claims that your product improves menstrual health. They also supply the documentation required for FDA and FTC compliance.
Ensuring that your product is clinically proven to improve psychological stress also improves consumer trust in your product's quality and capabilities, providing you a powerful marketing advantage.
Stress Reducing Claim Substantiation
With high quality clinical trials developed specifically for your unique product, you can gain access to new market claims. Over 50% of consumers rely on product claims when making supplement decisions, but use of claims requires high quality scientific substantiation. A clinical trial can make it possible to include phrases such as:
- Relieves stress and frustration
- For relief of nervous tension
- For stress, overwork, and fatigue
- Supports normal mental function
- For stress management
Claiming that your product reduces stress or boosts the stress response requires scientific substantiation, according to the FDA and FTC. The gold standard for this substantiation is to have clinical trials conducted on your specific product among people in your target market.
Franklin Health Research specializes in stress-reduction clinical trials through innovative methodology and measurements developed exclusively for this natural stress-relievers.
of women regularly consume natural supplements
of women experience symptoms associated with PMS
of supplement consumers expect to see clinical trials on their products
outcome measures for stress management
Stress management is typically considered to be a vague, abstract concept that cannot be measured, thus cannot be substantiated. Without the ability to measure an outcome, it becomes unlikely that a clinical trial can succeed at demonstrating that a product reduces a particular outcome.
This can be seen in the current body of research on stress-reducing products. The majority of research teams rely on outdated surveys or worse, nonspecific symptoms such as blood pressure or heart rate. Unlike factors which can be measured in a lab, such as nutrient levels or cholesterol, stress is a highly personal experience. Therefore the best source of data on stress response is the person experiencing stress.
Using the wrong measurement strategy guarantees that your study will fail to capture the stress-reducing strength of your product. Franklin Health Research solves this common problem through the use of a proprietary stress measurement tool developed exclusively for the natural products industry.
Capturing the psychological experience of stress requires a holistic approach capable of measuring the wide range of ways in which stress presents itself.
A comprehensive strategy for studying the stress measurement effects of a product may include factors such as cortisol testing, but should feature data which can more accurately capture the experiences and responses to stress that are most likely to show benefit from natural products.
Franklin Psychological Stress Scale (FPSS)
The Franklin Health Research multidisciplinary team of experts has developed and validated a comprehensive tool for quantifying psychological stress, including both acute situations (i.e. stage fright or test anxiety) and chronic situations (i.e. global unrest, workplace stress, daily struggles). This tool captures a holistic view of symptoms, delivering a comprehensive approach to identifying how your unique products improves stress during all phases of life. This also protects your trial from false negatives and enhances the potential for documenting a wider range of health benefits.
The comprehensive FPSS scale quantifies the extent to which your product improves well-being. It captures improvements to a wide range of stress-related domains, including affective, emotional, and cognitive stress responses. These are demonstrated through subjective, motivational, emotional, cognitive, behavioral, regulation, and anxiety subdomains. This comprehensive overview of symptoms allows our team to identify exactly how your product reduces stress, delivering robust substantiation for your claims.
the clinical trial process
Your project will begin with a 30-60 minute virtual meeting, during which we will learn everything we need to know about your product's key benefits so that we can capture them in a trial. Does your product help the body adapt to changes more easily? Or is it developed for a one-time use to combat stage fright or help college students deliver speeches? Perhaps it targets stress-related emotional states caused by routine daily stressors? Whatever your focus, your product formulation is unique and specific, and your clinical trial should reflect that.
Once we learn more about your product and your goals, our research team will develop a customized research proposal outlining just how we plan to capture your product's most significant benefits. We'll address all of the details from dosing strategies to trial duration, target market, and more, all while keeping your project budget in mind. Your proposal is good for 60 days, allowing ample time for internal reviews, requested adjustments, and other details. Once we execute a trial agreement, the fun begins!
working with franklin
Franklin Health Research is the only research firm in the supplement industry with deep roots in the natural products field. During our early days as an herbalism and aromatherapy college, we trained some of the nation's leading integrative health experts, and our team now focuses exclusively on high quality clinical research tailored to meet the unique needs of natural and botanically based products.
This foundation is critical to success with nutraceutical clinical research; without methods, measurements, and protocols developed specifically for the natural products industry, clinical trial projects can quickly become laden with unnecessary expenses, needless overhead, and outdated strategies borrowed from the pharmaceutical industry.
We build your trial around your specific product using strategies that protect your study from common sources of failure. i.e. Roughly 80% of nutraceutical trials fail to meet recruitment deadlines and the overwhelming majority fail to fully capture a nutraceutical's key benefits. Our innovative approaches based on our unique experience protects your study from common yet disastrous mistakes.