Immune Support

Clinical trials for immune-supporting natural products

Between the recent pandemic, the regular flu season, the common cold, and a myriad of other infectious diseases, immune systems are put to the test regularly. This may be why products promising immune support are among the highest grossing in the natural health industry.

You've got a product that enhances immune function, but today's consumers are burned out on the same old marketing campaigns and promises. They want proof. A clinical trial provides the evidence your brand needs to build consumer trust and keep the world healthier.

ENDPOINTS FOR IMMUNE HEALTH STUDIES

Finding the balance between making supplement claims such as "supports the immune system" and forbidden drug claims such as "prevents COVID-19" is easier said than done when it comes to clinical trials for natural products. To fully and accurately capture the benefits of natural immune support, you need the expertise of epidemiologists, the knowledge of aromatherapists, dietitians, or herbalists, and the proficiency of a clinical trialist.

Because of this complexity, many firms opt instead for treatment-focused trials, testing products on people who are already sick. This approach, however, can cause the FDA to reclassify your immune supporting product as a pharmaceutical, resulting in substantial costs both financially and opportunity.

So how do you prove that your aromatherapy blend, herbal supplement, or nutraceutical provides immune support for healthy people? Nutraceuticals Research Institute helps you meet this challenge with our proprietary Franklin Health Immune Status Scale (FHISS).

The FHISS is the first tool of its kind developed exclusively for the natural products industry to measure immune support in healthy individuals. This comprehensive measurement captures the accurate effects of immune support by focusing on a holistic understanding of the immune system as a whole. This tool enables our research team to document your product's effects on prevention, wellbeing, and susceptibility to disease in accordance with the regulatory guidelines for natural supplements.

A natural products immune support trial at Nutraceuticals Research Institute focuses on 6 primary endpoints, though your trial's endpoints will be hand-selected by our research team to match your product's greatest effects. Our standard immune health endpoints include:

Respiratory Symptoms

Documenting incidence, prevalence, and duration of respiratory symptoms confirms that product provides respiratory-focused immune support.

GI Symptoms

Documenting incidence, prevalence, and duration of GI symptoms confirms that product provides gastrointestinal-focused immune support.

Nonspecific Symptoms

Capturing general symptoms such as fever, muscle pain, or fatigue provides a clear overview of how well your product keeps people healthy.

Daily Function

Daily function scores indicate how well each participant is able to accomplish routine tasks thanks to a strong immune system.

Perspective

Perceived immune status indicates how well the participant believes their immune system is functioning.

Quality of Life

Documenting incidence, prevalence, and duration of dermal symptoms confirms that product provides skin-focused immune support.

Rotaviruses, the causative agents of diarrheal infection in children. 3D illustration
Motivated happy sporty woman wearing sports bra, sneakers enjoying excercise, training outdoors near sea, workout quay, jogging, running, jumping energized, smiling during productive fitness session.
B cells
Coughing beauty. Side view image of young sick woman with scarf on her neck sitting in bed and coughing with her country house on the background

IMMUNE HEALTH CLINICAL TRIALS

Capturing benefits to immune health involves monitoring health status on a daily basis for an extended period of time. Our team is specialized at this high level of participant monitoring to capture each and every symptom, leading to a larger effect size for your product.

Working with Nutraceuticals Research Institute for a high quality clinical trial with a immune-supportive outcome is a worthwhile investment as these studies have the potential to substantiate claims such as:

  • supports the immune system
  • improves immune health
  • protects immune health
  • boosts healthy immune function
  • delivers immune support

Immune health is typically selected as a primary endpoint for a nutraceutical study. Studies evaluating immune support can also be enhanced by adding outcomes such as sleep and stress.

Questions about Immune Support Trials

YOU KNOW YOUR PRODUCT WORKS; WE'LL HELP YOU PROVE IT.

Schedule a free, no-obligation meeting with a scientist today to learn more about how Nutraceuticals Research Institute can help your product become "clinically proven."