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KELSEY MORRIS THESIS FINAL FINAL2.pdf (2.71 MB)

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A soy product case study: Taking a functional food from the bench top to the clinic

Morris, Kelsey A, Morris
http://rave.ohiolink.edu/etdc/view?acc_num=osu1534510603861387

Abstract Details

2018, Master of Science, Ohio State University, Food Science and Technology.
There are various steps involved in functional food research and development that begin with identifying and characterizing a bioactive of interest, designing a specific food vehicle, optimizing the product, scaling up production for clinical trials, recruiting for and conducting a clinical trial, and addressing any challenges that occur. Most food science studies focus on the initial food development with little research on the requirements for effective functional food clinical studies or public health outcomes. Clinical trial results are often dependent on the dose of bioactive that a subject receives and it is of the utmost importance to ensure that each batch of scaled-up product delivers a comparable amount of bioactive. In the case of this study, the bioactive of interest was soy isoflavones delivered in the form of a soy soft pretzel snack. Various manufacturers were contacted for a contract manufacturing opportunity in order to mass-produce soy soft pretzels. Of three manufacturers that agreed to produce a test batch, one company has been able to recreate the sponge and dough process and a soy pretzel with an isoflavone concentration that is comparable to the bench top pretzel. Communications with this company will continue into the future as smaller “on-the-go” pretzel pieces are explored. Once a functional food has been produced, it can be assessed in a clinical setting. In the case of the soy soft pretzel, the cohort of interest was HIV+ individuals with high cholesterol and inflammation. HIV+ individuals are often afflicted with dangerously high cholesterol as a result of anti-retroviral therapy drugs (ART) that are prescribed to lower the viral load of HIV. Further, HIV+ individuals often live with chronic inflammation as a result of trace amount of the virus circulating throughout their system. Rather than prescribing additional medication to address these issues, a functional food approach was selected. The goal was to conduct a 6-week single-arm clinical study to determine the effects of soy soft pretzel consumption on hypercholesterolemia and inflammation in HIV+ individuals. Following several months of recruitment, only one individual completed the study, resulting in a lack of conclusions. To better understand the recruitment barriers experienced in the soy soft pretzel study for HIV+ individuals, a 10-question survey was developed to gain information on the attitudes and preferences of HIV+ individuals when it comes to clinical trial recruitment. Following three months of recruitment, 36 completed surveys were obtained. Initial results indicate that HIV+ individuals in central Ohio prefer trials that are recommended by a physician and impact the HIV+ community on a large scale. Incentives were not viewed as a participation motivator. Additionally, survey participants indicated that they would be comfortable completing a trial that lasted for one or more years and a trial that is within 40 miles of home. This information can be applied to better recruit for future clinical trials focused on the HIV+ population of central Ohio.
Yael Vodovotz (Advisor)
Nicholas Funderburg (Committee Member)
Devin Peterson (Committee Member)
107 p.
Food Science; Nutrition
Soy, HIV, Clinical Trials, Scaling Up, Barriers

Recommended Citations

Citations

  • Morris, Morris, K. A. (2018). A soy product case study: Taking a functional food from the bench top to the clinic [Master's thesis, Ohio State University]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=osu1534510603861387

    APA Style (7th edition)

  • Morris, Morris, Kelsey. A soy product case study: Taking a functional food from the bench top to the clinic. 2018. Ohio State University, Master's thesis. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=osu1534510603861387.

    MLA Style (8th edition)

  • Morris, Morris, Kelsey. "A soy product case study: Taking a functional food from the bench top to the clinic." Master's thesis, Ohio State University, 2018. http://rave.ohiolink.edu/etdc/view?acc_num=osu1534510603861387

    Chicago Manual of Style (17th edition)

osu1534510603861387
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