A New Paradigm for Conducting Nutritional Research Studies: Live ClinicalsTM

The Problem: Why Nutritional Researchers are Particularly Affected?

Non-government funding for nutritional and obesity research has been particularly hard hit for several reasons. Food companies are the likely candidates to fund nutritional research. However, these companies typically don’t fund studies, because rarely health claims can be made like those for pharmaceuticals. The Food and Drug Administration (FDA) only allows 13 drug-like health claims on food and supplements [5]. However, these aren’t attractive to companies, because they lack exclusivity [6]. For example, claims such as “calcium may reduce the risk of osteoporosis” or “fruits and vegetables, as part of a low-fat diet, may reduce the risk of some types of cancer,” while compelling, are not appealing for a single company to fund because so many sell these commodities. The first company-sponsored health claim was for oat beta glucan and cholesterol-lowering. Quaker Oats filed the claim with the FDA, but General Mills capitalized on it for its oat cereal, Cheerios. General Mils grew its brand without paying for the research. Ever since this, other companies have been leery to vie for a health claim. The fear of a financial conflict of interest with little up- side is another real problem, precluding food companies from funding nutritional research [7]. For example, the University of Colorado School of Medicine returned $1 Today, nutritional researchers lack proper funding, yet are still curious and available to conduct research. Clearly new strategies are needed, because the current funding pattern is unlikely to change. We propose a new model of collecting data in real-time, the Live Clinical. This model involves a triad of a company, the public including a company’s customers, and nutritional researchers. A company embracing this model must first be curious about how their foods perform, and second be willing to accept null or negative findings. The tenants of conducting research remain intact: hypothesis generation, data collection, statistical analysis, and manuscript preparation and submission (Table 1).

million gift from Coca-Cola after it was revealed that the money had been used to establish an advocacy group that played down the link between soft drinks and obesity [8]. This group of scientists urged people to focus more on exercise and worry less about what they eat and drink – something that is not supported by the bulk of research studies. The current norms for disclosure of nutritional researchers are inadequate and greater transparency is needed [7]. Unlike other scientific studies, such as looking at a rare form of cancer, nutritional studies have inherent investigator biases, because everyone eats. To overcome this, some have suggested that the nutritional preferences of the investigator be disclosed. For example, if a scientist shows that vegan diets are superior to other types and does not divulge that he or she is a vegan, then this could be perceived as investigator bias. In addition, unlike other scientific fields, the public is intensely interested in nutrition and often exposed to scads of unscientific information. Thus, food companies may pay for a high- quality study, with no one believing the findings.

The Solution: Live Clinicals

comments and videos -For publishing, the researcher will use participant-reported data

Five Novel Aspects of the Live Clinical exist

Cost: Using an academic center to conduct clinical research is costly in terms of the tests performed, patient recruitment, and overhead paid to the university. Contract research organizations are just as costly. A food company could expect to pay around $1,000,000. In contrast, a typical Live Clinical costs about $100,000. Duration of a Clinical Study: Typically, a clinical study in an academic center takes one to three years to complete. This includes securing a contract with the external relations department and gaining Institutional Review Board approval, which could take six months. A Live Clinical can be as long as the company wants, but typically two to eight weeks is the norm. Granted, there is preparation time to accrue participants and set up ways to collect data, but these are accomplished faster by company employees. Transparency: The public is skeptical about food companies, wondering if their advertising is true [7]. A Live Clinical model captures information from regular people eating the foods that the company sells. The participants are found through the company’s customer list and social outreach. They are asked to make regular posts on social media. All information is self-reported and (e.g., change in body weight, blood pressure, blood tests, questionnaires about quality of life issues). An academic researcher may serve as co-author. The researcher will not use in real-time, so the company needs to be willing to go at risk, if unfavorable remarks are made. Once started, data from a Live Clinical are there for the public to view and are unable to be redacted or influenced by the financial underwriter. Trust is established with the public, because the comments are unfiltered and generated by peers. This contrasts the lack of transparency at an academic center, where data are collected, filtered, and assembled for a scientific audience. With academic studies, the public learns nothing about how the participants feel or perform while eating the food. Even more troubling is that up to 85% of the published scientific literature may be wrong, with nutritional studies being among the worst [7, 9]. The need to publish only positive results fuels the problem. In 2015, 93% of the published studies funded by food companies favored the sponsor’s interest [10]. Failure of Scientific World to Deliver Messages on Healthy Eating: Social Networking: For the last 50 years, the prevalence of overweight and obese individuals has steadily increased [11]. This has lead to increases in chronic disease like cardiovascular disease, type 2 diabetes, stroke and hypertension, cancer, and cognitive dysfunction. The messaging on healthy eating to the public has not worked, and new ways of communication are needed. The old model for nutritional research has investigators sharing the results with their peers. Few studies are picked up by the media, and sometimes, those that are; do not convey the message properly. Social media has changed most areas of society and the scientific community is no exception [12]. It is engaging and can be experienced in real-time. User generated content creates more cognitive trust than marketer-generated content. In the new, Live Clinical model, data collection is in real-time and self reported from the participants. These go out to the public in a variety of social media outlets (e.g., Facebook, Instagram, YouTube, Twitter, etc.).

Over the past ten years, consumer purchasing habits are more shaped by what others think and less by what scientific findings say or what corporate advertising dictates. The recorded data from a Live Clinical can be obtained daily and are analogous to online marketing [13]. Most people (88%) trust online reviews from strangers as much as a personal recommendation. Having more reviews, whether they are good or bad, leads to a higher conversion rate, because the presence of bad reviews shows that the company isn’t to hide anything, and makes the good reviews seem more sincere. Start of “big data” for Healthcare: Healthcare is under attack by consumers, who are no longer shy about stating their dissatisfaction. People want their healthcare to be consumer-driven, user-friendly, convenient, transparent, and private [14]. Online shopping and banking are ubiquitous, so why can’t healthcare? Google, Amazon, and Apple are headed in this direction. These cash-flushed companies know how to collect data on all facets of someone’s life, develop profiles, and deliver an actionable recommendation. Partnerships are already forming between these giants and others with established healthcare systems. Amazon has partnered with Berkshire Hathaway and JP Morgan Chase, and CVS bought Aetna. The scientific world should embrace the new direction of healthcare, and through research, oversee that it’s done correctly.