Overview

This trial is active, not recruiting.

Conditions systemic inflammation, aging
Treatments fermented papaya preparation (fpp), sugar pill
Phase phase 2
Sponsor University of Florida
Collaborator Osato Research Institute
Start date October 2014
End date December 2016
Trial size 30 participants
Trial identifier NCT02051634, 20140628

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(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.
fermented papaya preparation (fpp) 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.
(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.
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.

Primary Outcomes

Measure
Interleukin-6 (IL-6) will be tested at week 8
time frame: Week 8
Interleukin-6 (IL-6) will be tested at week 20
time frame: Week 20
Tumor necrosis factor-α (TNF-α) will be tested at week 8.
time frame: Week 8
Tumor necrosis factor-α (TNF-α) will be tested at week 20.
time frame: Week 20
C - reactive protein (CRP) will be tested at week 8.
time frame: Week 8
C - reactive protein (CRP) will be tested at week 20.
time frame: Week 20
Myeloperoxidase (MPO) will be tested at week 8.
time frame: Week 8
Myeloperoxidase (MPO) will be tested at week 20.
time frame: Week 20

Secondary Outcomes

Measure
Short Physical Performance Battery
time frame: Week 8
Short Physical Performance Battery
time frame: Week 20
6 Minute Walk Test performed at week 8.
time frame: Week 8
6 Minute Walk Test, performed at week 20
time frame: Week 20
Health-related quality of life performed at week 8
time frame: Week 8
Health-related quality of life performed at week 20
time frame: Week 20
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at week 8.
time frame: Week 8
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at week 20.
time frame: Week 20
Brief Fatigue Symptom Inventory (FSI)
time frame: Week 8
Brief Fatigue Symptom Inventory (FSI) performed at week 20
time frame: Week 20
Superoxide dismutases (SOD) tested at week 8.
time frame: week 8
Superoxide dismutases (SOD) tested at week 20.
time frame: week 20
Glutathione Peroxidase tested at week 8.
time frame: week 8
Glutathione Peroxidase tested at week 20.
time frame: week 20
Total Antioxidant Capacity will be tested at week 8
time frame: week 8
Total Antioxidant Capacity will be tested at week 20.
time frame: Week 20
Muscle tissue oxygenation tested at week 8
time frame: week 8
Muscle tissue oxygenation at week 20
time frame: Week 20
Brain tissue oxygenation tested at week 8
time frame: Week 8
Brain tissue oxygenation tested at week 20
time frame: week 20

Eligibility Criteria

Male or female participants at least 70 years old.

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.

Additional Information

Official title Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation
Principal investigator Stephen D Anton, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Florida.