Heart Health

Validated psychometrics are best used in cases where the best quality data is obtained through self-report. When it comes to cardiac health, the best information comes from medical instruments such as a blood pressure cuff or serum cholesterol tests. 

Using those medical tests introduces a loss of the real world experience that we prioritize at NRI because entering a medical office is known to increase signs of stress, including cardiovascular symptoms. 

We address this challenge by using real world data collection tools. Clinical measurement studies have shown that smart watch-obtained heart rate scores are more valid and reliable than a one-time metric obtained in a medical office. This provides a more comprehensive understanding of heart rate patterns from day-to-day and delivers the same robust data collection you expect from us at NRI. 

We create each and every trial around your product's key benefits. The intervention period is going to be the driving factor in the trial's total duration. 

As a general rule, plan on 6-8 weeks from contract execution to the first participant's start date. This time is for customized protocol development and obtention of ethical authorizations/registrations. This is the most important timeframe of the entire study as it lays the groundwork for a trial that meets our high standards of quality and is capable of staying on the target timeline. 

Following the first participant's start date, we typically recommend adding 2 months to the total intervention period for us to hand-select each participant in your study among our nationwide community of participants. This means that a 1-week intervention would require approximately 9 weeks for this phase, whereas a 3-month intervention would require approximately 5 months. 

After all data are collected, our team audits each dataset to ensure accuracy. We then clean the data, construct the outcome variables from the data collected, and begin statistical analysis. This phase takes 4-6 weeks on average. More complex studies with multiple outcomes can take several months. 

Once outcomes are confirmed, we immediately provide you a quick review of the findings. Our team then spends another 2-4 weeks creating a long-form technical report that goes into precise details of the entire study, a submission-ready scientific manuscript for publication of the findings, and a full color lookbook which contains the technical report contents as well as attention catching graphs and charts. This ensures that everyone on your team, from legal to scientific to marketing, has access to the findings in the form that best meets their needs. 

With our approach of custom protocol creation for each clinical trial, we're able to reduce inefficiencies in the research process and eliminate needless overhead costs that are not relevant to the standards for health-enhancing products.  Not only does this approach substantially reduce the cost of a clinical trial for your stress product, it also improves the quality of the trial. It's a win-win. 

So what does this actually look like for your trial? At Franklin, we prioritize transparent pricing. Each and every trial is a bespoke design based on your product's unique needs, with your budget and goals in mind. With our extensive expertise in natural products and clinical research, we're often able to come up with creative solutions to work with any trial budget.

The typical randomized, double-blinded placebo-controlled clinical trial for a heart health product varies based on a number of factors. Most studies are in the 3-6 month intervention range and average $200-$300k. Our scientists will work with you to develop a heart health trial that captures the real world effects of your product while staying within the confines of your budget. 

Nutraceuticals often have a powerful effect on cardiovascular health, opening the door for a wide range of potential claims.  Working with Nutraceuticals Research Institute for a high-quality clinical trial with a heart-related outcome is a worthwhile investment as these studies have the potential to substantiate claims such as: 

• maintains healthy circulation
• promotes heart health
• supports the cardiovascular system 
• helps to maintain cardiovascular function
• supports a healthy circulatory system

Healthy cholesterol and blood pressure levels are common outcomes for heart-supporting nutraceuticals. Trials on heart health products can benefit from the inclusion of secondary or tertiary outcomes such as stress or mood.