The Efficient Brain Study

The design of this research study is to conduct a double-blind, randomized, placebo-controlled pilot study to determine whether FPP improves cerebral energy metabolism, neuroinflammation, systemic inflammation, cognitive function, fatigue, and health-related quality of life in older adults.

Potential participants will participate in a brief 10 minute phone screening that will describe the study. If participants meet initial inclusion/exclusion criteria on the phone screen, they will be scheduled for an in-person screening visit. Participants will attend five (5) in person visits including one Screening Visit performed individually for each potential study participant, and four Assessment Visits (V1-V4). Participants will be asked to provide a fasting blood sample that will be utilized to evaluate clinical laboratory parameters at the Screening visit and all four assessment visits. The participants will complete both a treatment and a placebo condition; therefore, a cross-over design will be used. After eight (8) weeks on each of these regimens, participants will be asked to complete post-treatment outcome assessments at the University of Florida's Institute on Aging - Clinical and Translational Research Building (IOA - CTRB). Following the first post-treatment test day (V2), participants will complete a six (6) week washout period and will then return to the IOA - CTRB to complete the other study arm. The order the participants receive FPP and placebo will be determined through randomization

Inclusion criteria

• Willing and able to participate in all aspects of the study;
• Not confined to a wheelchair;
• Evidence of cognitive aging based on Montreal Cognitive Assessment score less than or equal to 28, but greater than or equal to 23;
• Presence of elevated levels of systemic inflammation at screening (C-reactive protein levels > 1.0)
• 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;
• Dementia (e.g., Alzheimer's disease)
• Severe anemia (Hgb < 8.0 g/dL);
• Any blood or bleeding disorders;
• Liver or renal disease;
• Diabetes;
• Severe osteoarthritis;
• 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;
• History of significant head injury leading to cognitive impairments;
• Visual or hearing impairments that would interfere with testing;
• 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.