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HEART HEALTH
Clinical trials for cardiovascular supporting natural products
Heart health nutraceutical consumers are willing to invest in products that can deliver on their claims. The largest deciding factor when a consumer chooses a brand is clinical evidence. Standing out in this market requires clinical trials to produce the scientific proof these consumers require.
Natural product heart health studies often span multiple years or even decades, requiring thousands of participants. These trials are expensive and impractical for most natural products. But heart health trials don't have to be multi-year and multi-million dollar endeavors.
Cutting-edge, intelligent research designs can achieve the same goal for a fraction of the price in less than a year. Our expert scientists at Franklin Health create customized RCT protocols capable of demonstrating your products most powerful effects. This forward-thinking approach to clinical research provides you better results that are faster and more affordable.
Endpoints for Heart Health Studies
Consumers of heart health supplements typically have specific end goals in mind. They are worried about the effects aging may have on their blood pressure or cholesterol and want to give their cardiovascular system as much support as they can.
The right clinical trial creates consumer trust, giving them confidence that your product actually boosts brain health. Many clinical trials, however, focus on outcomes that don't matter to your customers, or fail to capture real world effects that translate to consumer benefits.
Our cardiovascular health studies include a myriad of key outcomes, ensuring that you not only substantiate your product claims, but also that you are able to quantify just how much your product boosts heart and vascular health. Some of the most common outcome measures we evaluate include EKG, heart rate, blood pressure, cholesterol, and triglycerides.
Many clinical trials have bloated infrastructure, requiring participants to come on site and have their heart rate and blood pressure checked in-person. Not only does this add unnecessarily to your study's cost, it delivers less-than-accurate results. Studies repeatedly show that the stress and hassle of on-site visits increase heart rate and blood pressure. Errors in these critical measures can result in trial failure.
Instead of time-consuming and budget-heavy on-site visits, we take advantage of modern technology to capture ongoing cardiovascular outcomes through smart watches or other wearable medical technology. Not only does this provide real-world results, it also provides multiple measures, ensuring accuracy.
In other words, we accurately capture your product's effects in real world settings–just like how your consumers will self-evaluate these benefits. We produce solid evidence that your product maintains healthy cholesterol levels, supports healthy blood pressure, and protects disruptions to heart rate. This allows you to make claims related to the real world benefits that your customers need most.
Heart Health Clinical Trials
Nutraceuticals often have a powerful effect on the skin, opening the door for a wide range of potential claims. Working with Franklin for a high quality clinical trial with a skin-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
Anti-aging is a common outcome for anti-oxidant dense products or other skin supporting nutraceuticals. Trials on anti-aging products can benefit from the inclusion of secondary or tertiary outcomes such as sleep or mood.
Questions About Heart Health Trials
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Do you have a validated heart health measurement?
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 Franklin Health 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 Franklin.
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How long does a heart health trial take?
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 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.
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How does your approach of custom protocol creation affect the budget?
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.
LET'S TALK
You know your product supports heart health; 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."