Papaya Study ID:20140628

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Collaborator: Osato Research Institute

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.