Systemic InflammationPhase 1NCT02051634
Papaya Study ID:20140628
A Phase 1 study testing Fermented Papaya Preparation (FPP) and Sugar Pill in people with Systemic Inflammation and Aging, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to explore the effects of fermented papaya preparation (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot study on FPP in older adults. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Inflammation, Aging
- What is being tested?
- Fermented Papaya Preparation (FPP) and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Body mass index > 25 and < 40 kg/m2;
- Willing and able to participate in all aspects of the study;
- Self-reported sedentary to moderately active lifestyle (<120 min aerobic activity/week);
- Self-reported ability to walk ¼ mile without the use of an assistive device (i.e., cane, walker, crutch);
- Mild to Moderate physical impairment (SPPB score 4-10);
- Not confined to a wheelchair;
- Mini Mental Status Exam score > 24;
- 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;
- Severe anemia (Hgb < 8.0 g/dL);
- Liver or renal disease;
Show all 26Show fewer
- Diabetes;
- Severe osteoarthritis;
- Fracture in upper or lower extremity within the last 6 months;
- Upper or lower extremity amputation;
- 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;
- Blood pressure with Systolic > 160mmHg and Diastolic >90mmHg;
- History of significant head injury leading to cognitive impairments;
- Visual or hearing impairments that would interfere with testing;
- Current consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum, grape seed extract, or ginko biloba;
- 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.
About this study
Official title: Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation
The purpose of this research study is to explore the effects of fermented papaya preparation (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot study on FPP in older adults. If FPP is found to have a beneficial impact on systematic inflammation in this study population (adults aged 70-100 years old), then this supplement may be a potential treatment option to combat aging.
Read the detailed description
All of the participants in this research study will be divided randomly into one of two groups: (1) a group taking fermented papaya preparation (FPP) for 8 weeks then taking placebo for 8 weeks or (2) a group taking placebo for 8 weeks then taking FPP for 8 weeks. Placebo sachets do not contain any treatment product. Participants will be assigned randomly to be in one of these two groups.
Participants will be asked to take study product for 8 weeks each, and participation in the study will last for a total of approximately 22 weeks. Participants will be asked to attend five study visits at the University of Florida's Institute on Aging - Clinical \& Translational Research Building (IOA - CTRB): Screening Visit, Visit 1, Visit 2, Visit 3, and Visit 4. Visit 1 will take place approximately 30 days after the Screening Visit. Visit 2 will take place approximately 8 weeks after the Screening Visit. Visit 3 will take place approximately 16 weeks after the Screening Visit. Visit 4 will take place approximately 20 weeks after the Screening Visit. Participants will be asked to fast (i.e., no food or liquids except water) for 8 hours prior to all clinic visits. Each visit will take approximately 1.5 to 2 hours.
Participants will also be called weekly during the study to ask how they are feel and to find out and if they remembered to take all of their study product. Finally, investigators will call approximately two weeks after participants stop taking the study product to ask how they are feeling.
- Conditions
- Systemic Inflammation, Aging
- Being tested
- Fermented Papaya Preparation (FPP), Sugar Pill
- Keywords
- Aging, Papaya, Fermented Papaya, Inflammation, Phytochemicals, Physical function, Quality of life, Fatigue, Health
- Medical subject headings
- Inflammation, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Papaya Preparation (FPP)Drug
Also called Papaya
A total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, slowly empty contents into their mouth, and let it dissolve before swallowing.
Sugar PillDrug
A total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once with breakfast, once with lunch, and once with dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing.
| Study group | Role | What they receive |
|---|---|---|
| Fermented Papaya Preparation (FPP) | Active comparator | A total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing. Receives: Drug: Fermented Papaya Preparation (FPP); Drug: Sugar Pill |
| Sugar Pill | Placebo comparator | A total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing. Receives: Drug: Fermented Papaya Preparation (FPP); Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6) will be tested at weeks 8 and 20
Blood test performed.
Measured: Change from 8 weeks and 20 weeks
Tumor necrosis factor-α (TNF-α) will be tested at weeks 8 and 20
Blood test will be performed.
Measured: Change from 8 weeks and 20 weeks
C - reactive protein (CRP) will be tested at weeks 8 and 20
Blood test will be performed.
Measured: Change from 8 weeks and 20 weeks
Myeloperoxidase (MPO) will be tested at weeks 8 and 20
Blood test will be performed.
Measured: Change from 8 weeks and 20 weeks
Secondary outcomes (10)
Short Physical Performance Battery
Physical function test to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test.
Measured: Change from 8 weeks and 20 weeks
6 Minute Walk Test performed at weeks 8 and 20.
The 6 Minute Walk tests functional walking endurance. Participants will be asked to walk at a comfortable pace for 6 minutes. Total distance completed, blood pressure, and pulse rate will be measured.
Measured: Change from 8 weeks and 20 weeks
Health-related quality of life performed at weeks 8 and 20
RAND SF-36 Short Form Health Survey (SF-36) measures eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality (energy/fatigue), emotional well being, bodily pain, social functioning, and general health perceptions.
Measured: Change from 8 weeks and 20 weeks
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20
FACIT-Fatigue is a measure of physical and functional consequences of fatigue, with lower scores indicating more fatigue.
Measured: Change from 8 weeks and 20 weeks
Brief Fatigue Symptom Inventory (FSI)
FSI is a measure of physical and functional consequences of fatigue.
Measured: Change from 8 weeks and 20 weeks
Superoxide dismutases (SOD) tested at weeks 8 and 20.
Blood test will be performed.
Measured: Change from 8 weeks and 20 weeks
Glutathione Peroxidase tested at weeks 8 and 20.
Blood test will be performed.
Measured: Change from 8 weeks and 20 weeks
Total Antioxidant Capacity will be tested at weeks 8 and 20
Blood test will be performed.
Measured: Change from 8 weeks and 20 weeks
Muscle tissue oxygenation tested at weeks 8 and 20
Participants will be asked to perform a leg extension endurance exercise with electrodes placed on their forehead and thigh.
Measured: Change from 8 weeks and 20 weeks
Brain tissue oxygenation tested at weeks 8 and 20
Participants will complete a series of memory and thinking tasks while wearing electrodes on their head. The N-Back Test that measures working memory will be conducted for 10 minutes.
Measured: Change from 8 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic InflammationStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, 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
- Stephen D Anton, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051634
- Sponsor's protocol ID
- IRB20140628
- Status last verified
- Apr 2018
- First submitted
- 29 Jan 2014
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation
- ClinicalTrials.gov ID
- NCT02051634
- Acronym / sponsor ID
- IRB20140628
- Conditions
- Systemic Inflammation, Aging
- Keywords
- Aging, Papaya, Fermented Papaya, Inflammation, Phytochemicals, Physical function, Quality of life, Fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Osato Research Institute
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to explore the effects of fermented papaya preparation (FPP) on whole body inflammation, physical function, fatigue, and health-related quality of life. The investigators will conduct a double-blind, randomized, placebo-controlled pilot study on FPP in older adults. If FPP is found to have a beneficial impact on systematic inflammation in this study population (adults aged 70-100 years old), then this supplement may be a potential treatment option to combat aging.
Detailed description
All of the participants in this research study will be divided randomly into one of two groups: (1) a group taking fermented papaya preparation (FPP) for 8 weeks then taking placebo for 8 weeks or (2) a group taking placebo for 8 weeks then taking FPP for 8 weeks. Placebo sachets do not contain any treatment product. Participants will be assigned randomly to be in one of these two groups.
Participants will be asked to take study product for 8 weeks each, and participation in the study will last for a total of approximately 22 weeks. Participants will be asked to attend five study visits at the University of Florida's Institute on Aging - Clinical \& Translational Research Building (IOA - CTRB): Screening Visit, Visit 1, Visit 2, Visit 3, and Visit 4. Visit 1 will take place approximately 30 days after the Screening Visit. Visit 2 will take place approximately 8 weeks after the Screening Visit. Visit 3 will take place approximately 16 weeks after the Screening Visit. Visit 4 will take place approximately 20 weeks after the Screening Visit. Participants will be asked to fast (i.e., no food or liquids except water) for 8 hours prior to all clinic visits. Each visit will take approximately 1.5 to 2 hours.
Participants will also be called weekly during the study to ask how they are feel and to find out and if they remembered to take all of their study product. Finally, investigators will call approximately two weeks after participants stop taking the study product to ask how they are feeling.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Papaya Preparation (FPP) | Active comparator | Drug: Fermented Papaya Preparation (FPP), Drug: Sugar PillA total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing. |
| Sugar Pill | Placebo comparator | Drug: Fermented Papaya Preparation (FPP), Drug: Sugar PillA total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Body mass index > 25 and < 40 kg/m2;
- Willing and able to participate in all aspects of the study;
- Self-reported sedentary to moderately active lifestyle (<120 min aerobic activity/week);
- Self-reported ability to walk ¼ mile without the use of an assistive device (i.e., cane, walker, crutch);
- Mild to Moderate physical impairment (SPPB score 4-10);
Key exclusion criteria (26 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;
- Severe anemia (Hgb < 8.0 g/dL);
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 Preparation (FPP)Also: PapayaA total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, slowly empty contents into their mouth, and let it dissolve before swallowing. | Drug | Fermented Papaya Preparation (FPP), Sugar Pill |
| Sugar PillA total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once with breakfast, once with lunch, and once with dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing. | Drug | Fermented Papaya Preparation (FPP), Sugar Pill |
Primary outcome
Interleukin-6 (IL-6) will be tested at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Blood test performed.
Tumor necrosis factor-α (TNF-α) will be tested at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Blood test will be performed.
C - reactive protein (CRP) will be tested at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Blood test will be performed.
Myeloperoxidase (MPO) will be tested at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Blood test will be performed.
10 secondary outcomes
Short Physical Performance Battery
Time frame: Change from 8 weeks and 20 weeks
6 Minute Walk Test performed at weeks 8 and 20.
Time frame: Change from 8 weeks and 20 weeks
Health-related quality of life performed at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Brief Fatigue Symptom Inventory (FSI)
Time frame: Change from 8 weeks and 20 weeks
Superoxide dismutases (SOD) tested at weeks 8 and 20.
Time frame: Change from 8 weeks and 20 weeks
Glutathione Peroxidase tested at weeks 8 and 20.
Time frame: Change from 8 weeks and 20 weeks
Total Antioxidant Capacity will be tested at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Muscle tissue oxygenation tested at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Brain tissue oxygenation tested at weeks 8 and 20
Time frame: Change from 8 weeks and 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
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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.
Stephen D Anton, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fermented Papaya Preparation (FPP) and Sugar Pill in people with Systemic Inflammation and Aging, 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 8 inclusion and 26 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 9 Apr 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interleukin-6 (IL-6) will be tested at weeks 8 and 20 (time frame: Change from 8 weeks and 20 weeks). The study lists 4 primary outcomes in all. 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 9 Apr 2018.