Clinical trials for stress-relieving natural products
Stress is complex. We make studying it simple.
Stress happens when there is a lack of balance between the demands (real or perceived) placed on a person and their capacity to face those demands. Roughly half of Americans suffer from nonstop stress caused by their jobs, the economy, the pandemic, or the general state of the world. This constant level of stress has a ripple effect on human health leading to digestive complaints, heart disease, weight gain, memory loss, and so much more.
Today's consumers want solutions to this widespread issue, and they've shown they're willing to invest in companies that bring proof. A clinical trial with Franklin Health can deliver the evidence your brand needs to stand out in this crowded market.
Endpoints for Stress Reduction Studies
To measure stress as an outcome, our team utilizes the Franklin Stress Scale (FSS), which is a comprehensive tool that captures the complexity of the stress response. It includes physical signs of stress, emotional symptoms of stress, maladaptive behaviors, the transactional mindset of individuals under chronic stress, and coping potential. This not only accurately captures your products effects on stress, it pinpoints exactly where your products greatest effects are seen.
A natural products stress trial at Franklin Health will typically focus on 7 - 8 key endpoints. Each product has unique needs, so your trial's specific endpoints will be determined through collaboration between your marketing goals and our research team, ensuring that they match your product's greatest effects. Our most commonly used endpoints include:
Physical effects of stress include headaches, muscle aches, tension, and tertiary symptoms such as sweaty palms. This subdomain captures the frequency and severity of these effects.
Chronic stress affects social-emotional well-being and is demonstrated through irritability, anxious thoughts, anger, lack of motivation, and related symptoms.
Stress levels can be assessed through behavioral capacity, including symptoms such as motivation, workplace productivity, procrastination, disordered eating habits, or nail biting.
Resilience captures the ability of the body to adapt to stress. Stress management products demonstrate effects through direct reductions, as well as through increases in adaptation.
The perceived stress subdomain refers to the extent to which a participant considers their demands to exceed their ability to cope. This measures whether or not the participant considers the product to be effective.
Biomarkers such as IL-6, IL-8, IL-17a, IFN-y, and alpha amylase provide laboratory evidence of reduced stress levels.
The cortisol awakening response measures the reactivity capacity of HPA axis which is involved in the regulation of the body after stressful events.
Stress Reduction Clinical Trials
The stress response is far from straight-forward. Unlike simplistic lab-related outcomes, such as blood pressure or cholesterol, the outcome of stress reflects a complex combination of both physical and psychological factors. Studying a product's effects on this psychological transaction requires experts who are both familiar with the neurobiology of stress and the benefits of psychometrics.
Working with Franklin for a high quality clinical trial with a stress-related outcome is a worthwhile investment as these studies have the potential to substantiate claims such as:
- reduces stress & frustration
- improves resilience
- supports emotional health
- alleviates occasional stress
- diminishes the effects of stress
Stress may be included in your trial, such as a primary endpoint for a professional burnout study, or a stress-reducing aromatherapy study. It is also frequently included as a secondary or exploratory endpoint for products that target outcomes which may influence stress.
Even if stress is not the primary focus of your product, including it as a secondary outcome can increase your potential claims. For example, improving sleep quality is known to boost stress adaptation. These secondary outcomes provide additional claim substantiation supporting your target outcome.
You know your product reduces stress; we'll help you prove it.
Schedule a free, no-obligation meeting with a scientist today to learn more about how Franklin can help your product become "clinically proven."