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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
30
A total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, slowly empty contents into their mouth, and let it dissolve before swallowing.
A total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once with breakfast, once with lunch, and once with dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing.
University of Florida
Gainesville, Florida, United States
Interleukin-6 (IL-6) will be tested at weeks 8 and 20
Blood test performed.
Time frame: Change from 8 weeks and 20 weeks
Tumor necrosis factor-α (TNF-α) will be tested at weeks 8 and 20
Blood test will be performed.
Time frame: Change from 8 weeks and 20 weeks
C - reactive protein (CRP) will be tested at weeks 8 and 20
Blood test will be performed.
Time frame: Change from 8 weeks and 20 weeks
Myeloperoxidase (MPO) will be tested at weeks 8 and 20
Blood test will be performed.
Time frame: Change from 8 weeks and 20 weeks
Short Physical Performance Battery
Physical function test to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test.
Time frame: Change from 8 weeks and 20 weeks
6 Minute Walk Test performed at weeks 8 and 20.
The 6 Minute Walk tests functional walking endurance. Participants will be asked to walk at a comfortable pace for 6 minutes. Total distance completed, blood pressure, and pulse rate will be measured.
Time frame: Change from 8 weeks and 20 weeks
Health-related quality of life performed at weeks 8 and 20
RAND SF-36 Short Form Health Survey (SF-36) measures eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality (energy/fatigue), emotional well being, bodily pain, social functioning, and general health perceptions.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Change from 8 weeks and 20 weeks
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20
FACIT-Fatigue is a measure of physical and functional consequences of fatigue, with lower scores indicating more fatigue.
Time frame: Change from 8 weeks and 20 weeks
Brief Fatigue Symptom Inventory (FSI)
FSI is a measure of physical and functional consequences of fatigue.
Time frame: Change from 8 weeks and 20 weeks
Superoxide dismutases (SOD) tested at weeks 8 and 20.
Blood test will be performed.
Time frame: Change from 8 weeks and 20 weeks
Glutathione Peroxidase tested at weeks 8 and 20.
Blood test will be performed.
Time frame: Change from 8 weeks and 20 weeks
Total Antioxidant Capacity will be tested at weeks 8 and 20
Blood test will be performed.
Time frame: Change from 8 weeks and 20 weeks
Muscle tissue oxygenation tested at weeks 8 and 20
Participants will be asked to perform a leg extension endurance exercise with electrodes placed on their forehead and thigh.
Time frame: Change from 8 weeks and 20 weeks
Brain tissue oxygenation tested at weeks 8 and 20
Participants will complete a series of memory and thinking tasks while wearing electrodes on their head. The N-Back Test that measures working memory will be conducted for 10 minutes.
Time frame: Change from 8 weeks and 20 weeks