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Human Clinical Trial Participation: The Inside Scoop

November 17, 2015

I gave blood samples, drank smoothies blended from whole fruits and vegetables, and limited my diet – all in the name of science. I was one of 25 people between the ages of 21 and 45 with a body mass index (BMI) between 18.5 and 27.0 recruited by the UNC Chapel Hill Nutrition Research Institute (NRI) on the NC Research Campus (NCRC) in Kannapolis, North Carolina to take part in a research study looking at the antioxidants in fruits and vegetables.

I had never taken part in a research study before. As a person fascinated by science and who is pursuing a career in science writing, I felt compelled to give it a try when I saw the notice in a newsletter of a study that needed people to drink smoothies. I figured that it couldn’t be too hard. To get started, all I had to do was send an email to the NRI.

Kara-Marker_DHMRI

Kara Marker

The Study Experience

The first thing I had to do was sign a consent form and commit to giving the study three days, each two weeks apart. The night before each study day, I had to stop eating or drinking at 10 pm. When I arrived early the next morning, the day started with a blood draw and then a smoothie. I had blood samples
taken three times on each study day, and I returned the next morning to provide one more. The medical technicians were experts at taking blood draws. They were quick and virtually painless. Part of what made the study interesting was the flavor of each smoothie. Some weren’t bad, and others weren’t flavors I’d recommend whipping up in the morning.

The technicians were also very friendly showing me to the lounge with Wi-Fi, cable television, a comfortable couch, computers and work space to wait with two other participants throughout the day. I was able to surf the internet, watch TV, and relax – things I do at home – while earning money. On each study day, the NRI provided snacks, lunch, and dinner so they could control my food intake and ensure any significant results could be pinpointed to the smoothies. I was amazed at how little effort it took on my part to help advance nutrition science.

The Science Behind the Study

As a study participant, you may not find out the details behind your study. Since I am an intern at the NCRC, I found out that my study was prompted by results from a collaborative research project by scientists at the NRI and the Dole Nutrition Institute (DNI) that was published in the Journal of Nutrition. Instead of the traditional focus on antioxidants and the phytochemicals that attack free radicals, the study examined how antioxidant response elements (AREs) activate internal defense systems. AREs are found in the peels and flesh of many fruits and vegetables, and they control the expression of cellular functions that defend the body against free radicals.

By taking my blood before and after drinking the smoothie, the researchers could analyze the content and activation of AREs as they circulate in my body. I ate the same snacks, lunch, and dinner as the other participants, and we did not eat or drink anything other than what was provided at the study. By controlling our diet so precisely, the researchers knew that no unexpected variables could be skewing the data. By compiling my results with the other study participants, these scientists will be able to deepen their scientific understanding of how antioxidant phytochemicals promote human health and prevent disease.

Participating in this research study was a good fit for me, but I believe it is something anyone who is interested in science, nutrition and improving human health can do. Getting involved as a research study participant in a human clinical trial is as easy as liking the UNC NRI Facebook page or subscribing to the NCRC e-newsletter. Other NCRC partners also host studies that recruit participants: Duke University MURDOCK Study, Spectrum Discovery Center, and Appalachian State University Human Performance Lab.

By Kara Marker, NCRC Marketing Intern

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