Papaya Study ID:20140628

• ClinicalTrials.gov Identifier: NCT02051634
• Recruitment Status: Completed
• First Posted: January 31, 2014
• Last Update Posted: April 9, 2018
• Sponsor: University of Florida
• Collaborator: Osato Research Institute
• Information provided by (Responsible Party): University of Florida

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Systemic Inflammation; Aging	Drug: Fermented Papaya Preparation (FPP); Drug: Sugar Pill	Phase 1

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation
• Study Start Date: October 2014
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Fermented Papaya Preparation (FPP); 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.	Drug: Fermented Papaya Preparation (FPP); 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.; Other Name: Papaya; Drug: Sugar Pill; 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.
Placebo Comparator: Sugar Pill; 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.	Drug: Fermented Papaya Preparation (FPP); 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.; Other Name: Papaya; Drug: Sugar Pill; 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.

Outcome Measures

Primary Outcome Measures :

1. Interleukin-6 (IL-6) will be tested at weeks 8 and 20 [ Time Frame: Change from 8 weeks and 20 weeks ]
   Blood test performed.
2. 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.
3. 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.
4. Myeloperoxidase (MPO) will be tested at weeks 8 and 20 [ Time Frame: Change from 8 weeks and 20 weeks ]
   Blood test will be performed.

Secondary Outcome Measures :

1. Short Physical Performance Battery [ Time Frame: Change from 8 weeks and 20 weeks ]
   Physical function test to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test.
2. 6 Minute Walk Test performed at weeks 8 and 20. [ Time Frame: Change from 8 weeks and 20 weeks ]
   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.
3. Health-related quality of life performed at weeks 8 and 20 [ Time Frame: Change from 8 weeks and 20 weeks ]
   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.
4. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20 [ Time Frame: Change from 8 weeks and 20 weeks ]
   FACIT-Fatigue is a measure of physical and functional consequences of fatigue, with lower scores indicating more fatigue.
5. Brief Fatigue Symptom Inventory (FSI) [ Time Frame: Change from 8 weeks and 20 weeks ]
   FSI is a measure of physical and functional consequences of fatigue.
6. Superoxide dismutases (SOD) tested at weeks 8 and 20. [ Time Frame: Change from 8 weeks and 20 weeks ]
   Blood test will be performed.
7. Glutathione Peroxidase tested at weeks 8 and 20. [ Time Frame: Change from 8 weeks and 20 weeks ]
   Blood test will be performed.
8. Total Antioxidant Capacity will be tested at weeks 8 and 20 [ Time Frame: Change from 8 weeks and 20 weeks ]
   Blood test will be performed.
9. Muscle tissue oxygenation tested at weeks 8 and 20 [ Time Frame: Change from 8 weeks and 20 weeks ]
   Participants will be asked to perform a leg extension endurance exercise with electrodes placed on their forehead and thigh.
10. Brain tissue oxygenation tested at weeks 8 and 20 [ Time Frame: Change from 8 weeks and 20 weeks ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Contacts and Locations

Locations

United States, Florida

University of Florida

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Osato Research Institute

Investigators

• Principal Investigator: Stephen D Anton, PhD; University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02051634
• Other Study ID Numbers: IRB20140628
• First Posted: January 31, 2014
• Last Update Posted: April 9, 2018
• Last Verified: April 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:

Aging; Papaya; Fermented Papaya; Inflammation; Phytochemicals; Physical function; Quality of life; Fatigue; Health

Additional relevant MeSH terms:

Inflammation; Pathologic Processes