Metabolism - Cerebral EnergyPhase 2NCT02771366
The Efficient Brain Study
A Phase 2 study testing Fermented Papaya Preparation and Granulated Sugar in people with Metabolism - Cerebral Energy, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism - Cerebral Energy
- What is being tested?
- Fermented Papaya Preparation and Granulated Sugar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 27 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Institute on Aging
Gainesville, Florida, 32610
About this study
Official title: The Influence of Fermented Papaya Preparation (FPP) on Cerebral Energy Metabolism, Neuroinflammation, and Cognition in Older Adults
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.
Read the 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 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
- Conditions
- Metabolism - Cerebral Energy
- Being tested
- Fermented Papaya Preparation, Granulated Sugar
- Keywords
- neuroinflammation, cognitive function, aging adults
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Papaya PreparationDrug
Also called FPP
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.
Granulated SugarOther
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: 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, Receives: Drug: Fermented Papaya Preparation; Other: Granulated Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startNov 2016
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolism - Cerebral EnergyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Osato Research Institute
- Responsible party
- Sponsor
- Investigators
- Adam Woods, Ph.D, Principal investigator, University of Flrodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771366
- Sponsor's protocol ID
- 00005695 -rev. comments
- Status last verified
- Oct 2019
- First submitted
- 11 Mar 2016
- Last updated
- 17 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Fermented Papaya Preparation (FPP) on Cerebral Energy Metabolism, Neuroinflammation, and Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT02771366
- Acronym / sponsor ID
- 00005695 -rev. comments
- Conditions
- Metabolism - Cerebral Energy
- Keywords
- neuroinflammation, cognitive function, aging adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Osato Research Institute
- Study start
- Nov 2016
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 17 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Papaya Preparation, then granulated sugar | Experimental | Drug: Fermented Papaya Preparation, Other: Granulated SugarParticipants 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, |
| Granulated Sugar, then Fermented Papaya Preparation | Placebo comparator | Drug: Fermented Papaya Preparation, Other: Granulated SugarParticipants 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, |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented Papaya PreparationAlso: FPPThis 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. | Drug | Fermented Papaya Preparation, then granulated sugar, Granulated Sugar, then Fermented Papaya Preparation |
| Granulated SugarAlso: PlaceboThis 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. | Other | Fermented Papaya Preparation, then granulated sugar, Granulated Sugar, then Fermented Papaya Preparation |
Primary outcome
Magnetic Resonance Spectroscopy (MRS) Will Measure a Change in Cerebral Energy Function in Brain Tissue
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Woods, Ph.D principal investigator
University of Flrodia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fermented Papaya Preparation and Granulated Sugar in people with Metabolism - Cerebral Energy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Spectroscopy (MRS) Will Measure a Change in Cerebral Energy Function in Brain Tissue (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.