The Efficient Brain Study
Completed · Phase 2 · Has a placebo group
Conditions studied: Metabolism - Cerebral Energy
In brief
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). In addition, age-associated increase in systemic and neuroinflammation is associated with a higher likelihood for development of Alzheimer's disease and neurodegenerative disease in older adults. Furthermore, decreased cerebral energy metabolism and increased neuroinflammation are both associated with deficits in cognitive function, even in the absence of neurodegenerative disease. In older adults, decreased cognition is strongly associated with the development of AD, increased rates of hospitalization, loss of functional independence, and increased mortality rate. Novel methods for preventing cognitive decline and neurodegenerative diseases in older adults are needed the world's aging population. Current research suggests that nutrients in fruits and vegetables produce strong anti-oxidant and anti-proliferative effects. Most Americans are not consuming the minimum recommendations of fruits and vegetables per day to receive these benefits. Whole food-based nutritional products, such as Fermented Papaya Product (FPP), may provide a healthy alternative for individuals. FPP, which is made by bio-fermentation of Carica papaya, has been found to enhance antioxidant protection and to decrease DNA damage in healthy older adults. Furthermore, if FPP increases cerebral energy metabolism and down-regulates neuroinflammation, with resulting effects on cognition, dietary supplementation with FPP may have preventative benefits for age-related cognitive conditions, including MCI, AD, Parkinson's disease and other neurodegenerative diseases.
Key facts
- Study ID
- NCT02771366
- Run by
- University of Florida
- People needed
- 30
- Starts
- 2016-11-01
- Expected to finish
- 2018-07-27
- Last updated by the study team
- 2019-10-17
Who can join
Age: 65 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Florida Institute on Aging — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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