- Clinical trials -

Immune Support

Many natural products claim to offer immune support; show your customers the power of your product with a clinical trial.

 

clinical trials for immune support

Products offering immune support at among the highest grossing in the natural health field, but consumers know that many of these products fail to deliver. How do you build trust? Clinical trials are key to substantiating these claims and showing just how much your product can achieve. 

Consumers of natural products prioritize prevention. A clinical trial demonstrating your product's immune protective abilities makes a powerful statement to your customers about your product's abilities. Clinically proven immune enhancing effects elevate your product above the competition with a marketing edge few can attain.

With a published clinical trial, you can also unlock new claims about your product's actions on the human body, legally and ethically making claims that your product boosts immune function and protects the immune system. 

Documenting just how much your product protects human health proves consumer confidence in your product's efficacy. It also serves as claim substantiation, which the FDA and FTC require you to have before marketing your product for immune health. 

Immune Health Claim Substantiation

High quality clinical trials, developed to demonstrate your product's unique effects within your target market, are required by regulatory authorities for any marketing claims regarding immune support. 

With properly designed and implemented clinical trials, you can unlock the ability to legally and ethically make claims such as: 

  • Stimulates the immune system 
  • Supports healthy immune function 
  • Promotes a healthy immune system
  • Clinically studied to benefit the natural and acquired immune systems 
  • Has strong influence on the human immune system
  • Promotes lung health 
  • Enhances respiratory health 
  • Promotes gastrointestinal health

While it is commonly believed these claims can be made by anyone, so long as they include the FDA disclaimer (i.e. These claims have not been evaluated...), or that claims can be made so long as the product's ingredients are cited in existing clinical studies, such misconceptions can be costly and dangerous to your brand's reputation.  Franklin Health Research can help your immune boosting products earn the right to make these claims, confidently assuring your customers of your product's efficacy and your brand's integrity. 

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of typical nutraceutical clinical trials fail to meet enrollment goals

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of willing trial participants are in the Franklin Health research database

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is the risk of trial failure most clinical trial organizations deliver

outcome measures for immune health

To purpose of a clinical trial for claim substantiation is clear: document efficacy. A trial for natural products involves measuring the effect of your product in a treatment group and comparing it to a placebo group. This is done using statistical tests which can establish whether or not the difference in immune health can be attributed to the treatment. The key to this process is outcome measurement. 

 If the wrong tool is used to measure immune health, your entire trial is at risk of failure.

Despite the clear importance of using the correct measurement tools, the overwhelming majority of measurement tools used in clinical research on immune health are borrowed from pharmaceutical research which is designed to capture levels of sickness, not levels of health. This differs from the goal of consumers of natural products, who ingest immune supporting products to help their immune systems do their jobs efficiently and effectively. 

Tools to measure disease are incapable of capturing the benefits of an immune supportive product to an already healthy individual. The failure to accurately measure your product's effects can destroy your clinical trial. Franklin Health Research solves this common problem through the use of proprietary immune health measurement tools developed exclusively for the natural products industry. 

 

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Franklin Immune Status Scale (FISS)

The Franklin Health Research team developed and validated the first measurement of immune status designed for healthy individuals taking dietary supplements. The FISS more accurately captures the strength of your product's immune boosting effects and protects your trial from false negatives.

This comprehensive scale evaluates immune status as more than a simple dichotomous healthy-sick option; it captures a wide range of immune-related symptoms, including incidence, severity, and duration of respiratory health, gastrointestinal health, dermal symptoms, and physical well-being, in addition to quality of life and function scores. 

This holistic approach enables our researchers to capture not only the size of your product's effects on immune status but also the specificity of where your product's biggest effects can be found. 

Unlike tools used to measure disease status, the FISS was validated for use in a healthy population which resembles the most common purchasers of natural products and nutraceuticals. This ensures that your study's population matches your consumers–a critical, yet often overlooked, point of compliance for substantiating product claims. 

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THE PROCESS OF STUDYING YOUR Immune enhancing PRODUCT

Each clinical trial project begins with a 30-60 minute virtual meeting, allowing our team to obtain a comprehensive overview of your product's unique features and your marketing goals for this clinical trial. Does your product help school aged children stay healthier during the school year? Or is it targeted towards frequent travelers who are exposed to a wide range of new pathogens? Perhaps your target market consists of elderly individuals living in assisted living facilities with enhanced exposure? Whatever the market, our team can ensure that your trial is customized to meet your specific marketing goals and associated compliance requirements. 

Once we're familiar with your needs, our team of trial experts will design a proposal based on the features of your immune supporting product. We'll ensure the dosing strategy matches your product's formulation and delivery, that the duration is sufficient to capture measurable change, and that the population is the exact population who will benefit most from using your product. And we'll develop each of these features keeping your budget in mind. 

working with franklin

When choosing a research firm to work with your products, it's important to find the right fit. Most research organizations specialize in pharmaceutical development and conduct natural product studies on the side. The danger to this approach is they typically fail to capture the nuance of natural products and apply inappropriate research methodologies. These clinical trials can quickly become extremely costly, time consuming, and labor-intensive projects, adding bloat to the budget and still failing to meet the unique needs of the natural products industry.

From its inception as an institution of higher education in 2013, Franklin Health Research has always focused exclusively on natural products. Our college programs taught some of the nation's leading herbalists and aromatherapists, and our researcher team is comprised of experts trained in both integrative health and advanced research methods. 

Our expertise also allows us to build your trial from the group up using strategies that protect it from common sources of failure. Many trials suffer from recruitment failure, loss to followup, and woefully inadequate statistical strategies. We've developed unique and innovative approaches to protect your study from these common yet disastrous hurdles. From a comprehensive nationwide database of study participants to an attentive participant support and management team, our role is to anticipate and solve vulnerabilities before they cause problems with your trial. 

 

Clinical Trials for immune support Products

Ready to get started? Schedule your FREE 30-minute consultation with our research team to discuss your strategies and needs. 

 

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