Aging Clinical Trial
Official title:
Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation
The purpose of this research study is to explore the effects of fermented papaya preparation (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot study on FPP in older adults. If FPP is found to have a beneficial impact on systematic inflammation in this study population (adults aged 70-100 years old), then this supplement may be a potential treatment option to combat aging.
All of the participants in this research study will be divided randomly into one of two
groups: (1) a group taking fermented papaya preparation (FPP) for 8 weeks then taking placebo
for 8 weeks or (2) a group taking placebo for 8 weeks then taking FPP for 8 weeks. Placebo
sachets do not contain any treatment product. Participants will be assigned randomly to be in
one of these two groups.
Participants will be asked to take study product for 8 weeks each, and participation in the
study will last for a total of approximately 22 weeks. Participants will be asked to attend
five study visits at the University of Florida's Institute on Aging - Clinical &
Translational Research Building (IOA - CTRB): Screening Visit, Visit 1, Visit 2, Visit 3, and
Visit 4. Visit 1 will take place approximately 30 days after the Screening Visit. Visit 2
will take place approximately 8 weeks after the Screening Visit. Visit 3 will take place
approximately 16 weeks after the Screening Visit. Visit 4 will take place approximately 20
weeks after the Screening Visit. Participants will be asked to fast (i.e., no food or liquids
except water) for 8 hours prior to all clinic visits. Each visit will take approximately 1.5
to 2 hours.
Participants will also be called weekly during the study to ask how they are feel and to find
out and if they remembered to take all of their study product. Finally, investigators will
call approximately two weeks after participants stop taking the study product to ask how they
are feeling.
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