Clinical trial NCT02051634: Papaya Study ID:20140628
Official title: Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Inflammation
Aging
Keywords: Aging
Papaya
Fermented Papaya
Inflammation
Phytochemicals
Physical function
Quality of life
Fatigue
Health
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Osato Research Institute
First posted: 2014-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Interleukin-6 (IL-6) will be tested at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
measure: Tumor necrosis factor-α (TNF-α) will be tested at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
measure: C - reactive protein (CRP) will be tested at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
measure: Myeloperoxidase (MPO) will be tested at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Change from 8 weeks and 20 weeks
measure: 6 Minute Walk Test performed at weeks 8 and 20.
timeFrame: Change from 8 weeks and 20 weeks
measure: Health-related quality of life performed at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
measure: Brief Fatigue Symptom Inventory (FSI)
timeFrame: Change from 8 weeks and 20 weeks
measure: Superoxide dismutases (SOD) tested at weeks 8 and 20.
timeFrame: Change from 8 weeks and 20 weeks
measure: Glutathione Peroxidase tested at weeks 8 and 20.
timeFrame: Change from 8 weeks and 20 weeks
measure: Total Antioxidant Capacity will be tested at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
measure: Muscle tissue oxygenation tested at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
measure: Brain tissue oxygenation tested at weeks 8 and 20
timeFrame: Change from 8 weeks and 20 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Stephen D Anton, PhD
role: PRINCIPAL_INVESTIGATOR
References: