Papaya Study ID:20140628
Completed · Phase 1 · Has a placebo group
Conditions studied: Systemic Inflammation, Aging
In brief
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.
Key facts
- Study ID
- NCT02051634
- Run by
- University of Florida
- People needed
- 30
- Starts
- 2014-10-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-04-09
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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