The Efficient Brain Study

NCT02771366 | Completed Phase 2 Results DMC

• 1 other identifier: 00005695 -rev. comments
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Metabolism - Cerebral Energy

Keywords

neuroinflammation; cognitive function; aging adults

Outcome Measures

Primary Outcomes (1)

• Magnetic Resonance Spectroscopy (MRS) Will Measure a Change in Cerebral Energy Function in Brain Tissue

  Cerebral energy metabolism will be defined by phosphorus magnetic resonance spectroscopy markers of ATP/mitochondrial function in brain tissue (α-ATP, β-ATP, and γ-ATP). Within-subject crossover design; difference between drug and placebo arms. Treatment duration: weeks 0-8 followed by washout then weeks 14 to 22. Data reported in the outcome measures data table represents difference between pre and post measurement values (post-pre) for each arm.

  Participants received MRS at weeks 0, 8, 14, and 22. Data reported in the outcome measures data table represents difference between pre and post measurement values (post-pre) for each arm.

Study Arms (2)

Fermented Papaya Preparation, then granulated sugar

EXPERIMENTAL

Participants will start taking the Fermented Papaya Preparation (FPP) three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the granulated sugar in the same way as the FPP was taken. In addition, the following test will be performed: Magnetic Resonance Spectroscopy (MRS) of the brain, functional magnetic resonance imaging (fMRI), RAND 36-item Health Survey (SF-36) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) blood samples,

Drug: Fermented Papaya Preparation; Other: Granulated Sugar

Granulated Sugar, then Fermented Papaya Preparation

PLACEBO COMPARATOR

Participants will start taking the granulated sugar three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the Fermented Papaya Preparation (FPP) in the same way as the granulated sugar was taken. In addition, the following test will be performed: Magnetic Resonance Spectroscopy (MRS) of the brain, functional magnetic resonance imaging (fMRI), RAND 36-item Health Survey (SF-36) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) blood samples,

Drug: Fermented Papaya Preparation; Other: Granulated Sugar

Interventions

Fermented Papaya Preparation DRUG

This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.

Also known as: FPP

Fermented Papaya Preparation, then granulated sugar; Granulated Sugar, then Fermented Papaya Preparation

Granulated Sugar OTHER

This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.

Also known as: Placebo

Fermented Papaya Preparation, then granulated sugar; Granulated Sugar, then Fermented Papaya Preparation

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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;

Sponsors & Collaborators

• University of Florida: lead
• Osato Research Institute: collaborator

Study Sites (1)

University of Florida Institute on Aging

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Neuroinflammatory Diseases

Interventions

fermented papaya preparation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Adam Woods, Ph.D.
• Organization: University of Florida

ajwoods@phhp.ufl.edu

352-294-5842

Study Officials

• Adam Woods, Ph.D

  University of Flrodia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: May 13, 2016
• Study Start: November 1, 2016
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: October 17, 2019
• Results First Posted: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)