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Phase 2 N=30 Randomized Double-blind Treatment

The Efficient Brain Study

Metabolism - Cerebral Energy

Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Oct 2019
Primary outcome: Primary: Magnetic Resonance Spectroscopy (MRS) Will Measure a Change in Cerebral Energy Function in Brain Tissue — .011; .007; .009; .006 Difference in metabolite amplitude

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Fermented Papaya Preparation (Drug); Granulated Sugar (Other)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
University of Florida
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Magnetic Resonance Spectroscopy (MRS) Will Measure a Change in Cerebral Energy Function in Brain Tissue
.011; .007; .009; .006; .020; .013

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). 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.

Eligibility Criteria

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 ( 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02771366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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