Status:
COMPLETED
The Efficient Brain Study
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Osato Research Institute
Conditions:
Metabolism - Cerebral Energy
Eligibility:
All Genders
65-100 years
Phase:
PHASE2
Brief Summary
Cerebral energy metabolism declines with advanced aging, and is implicated in age-related cognitive decline, Alzheimer's disease (AD), and other forms of neurodegenerative disease (Parkinson's disease...
Detailed Description
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 inf...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02771366
Start Date
November 1 2016
End Date
July 27 2018
Last Update
October 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Florida Institute on Aging
Gainesville, Florida, United States, 32610