Papaya Study ID:20140628

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.

Inclusion criteria

• Body mass index > 25 and < 40 kg/m2;
• Willing and able to participate in all aspects of the study;
• Self-reported sedentary to moderately active lifestyle (<120 min aerobic activity/week);
• Self-reported ability to walk ¼ mile without the use of an assistive device (i.e., cane, walker, crutch);
• Mild to Moderate physical impairment (SPPB score 4-10);
• Not confined to a wheelchair;
• Mini Mental Status Exam score > 24;
• Able to swallow study product as directed.

Exclusion criteria

• Failure to give consent;
• Active treatment for cancer (< 3 years);
• Stroke (< 6 mo);
• Serious heart condition, peripheral vascular disease, coronary artery disease (myocardial infarction<6 mo), Class III, IV Congestive Heart Failure;
• Severe anemia (Hgb < 8.0 g/dL);
• Liver or renal disease;
• Diabetes;
• Severe osteoarthritis;
• Fracture in upper or lower extremity within the last 6 months;
• Upper or lower extremity amputation;
• Anticoagulant therapy (aspirin use is permitted);
• Parkinson's disease;
• Severe psychiatric disease or psychological disorder (e.g., severe depression, bi-polar disorder, schizophrenia) or current use of antipsychotics;
• Current use of anabolic medications (e.g., growth hormone or testosterone) or anticholinesterase inhibitor (i.e., Aricept);
• High amounts of physical activity (i.e., running, bicycling, etc.) > 120 min/week;
• Excessive alcohol use (>2 drinks per day);
• Use of tobacco products;
• Resting heart rate > 120 bpm;
• Blood pressure with Systolic > 160mmHg and Diastolic >90mmHg;
• History of significant head injury leading to cognitive impairments;
• Visual or hearing impairments that would interfere with testing;
• Current consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum, grape seed extract, or ginko biloba;
• Allergies to papaya or foods with similar compounds (i.e., banana, avocado, kiwi, chestnuts, hazel nuts)
• Allergy to latex;
• Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment;
• Center for Epidemiological Studies - Depression Scale (CES-D) Score > 20.