Aging Clinical Trial
Official title:
Efficacy of Fermented Papaya Preparation on Markers of Systemic Inflammation
Verified date | April 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility |
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 ΒΌ 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Osato Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Interleukin-6 (IL-6) will be tested at weeks 8 and 20 | Blood test performed. | Change from 8 weeks and 20 weeks | |
Primary | Tumor necrosis factor-a (TNF-a) will be tested at weeks 8 and 20 | Blood test will be performed. | Change from 8 weeks and 20 weeks | |
Primary | C - reactive protein (CRP) will be tested at weeks 8 and 20 | Blood test will be performed. | Change from 8 weeks and 20 weeks | |
Primary | Myeloperoxidase (MPO) will be tested at weeks 8 and 20 | Blood test will be performed. | Change from 8 weeks and 20 weeks | |
Secondary | Short Physical Performance Battery | Physical function test to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test. | Change from 8 weeks and 20 weeks | |
Secondary | 6 Minute Walk Test performed at weeks 8 and 20. | 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. | Change from 8 weeks and 20 weeks | |
Secondary | Health-related quality of life performed at weeks 8 and 20 | 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. | Change from 8 weeks and 20 weeks | |
Secondary | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) performed at weeks 8 and 20 | FACIT-Fatigue is a measure of physical and functional consequences of fatigue, with lower scores indicating more fatigue. | Change from 8 weeks and 20 weeks | |
Secondary | Brief Fatigue Symptom Inventory (FSI) | FSI is a measure of physical and functional consequences of fatigue. | Change from 8 weeks and 20 weeks | |
Secondary | Superoxide dismutases (SOD) tested at weeks 8 and 20. | Blood test will be performed. | Change from 8 weeks and 20 weeks | |
Secondary | Glutathione Peroxidase tested at weeks 8 and 20. | Blood test will be performed. | Change from 8 weeks and 20 weeks | |
Secondary | Total Antioxidant Capacity will be tested at weeks 8 and 20 | Blood test will be performed. | Change from 8 weeks and 20 weeks | |
Secondary | Muscle tissue oxygenation tested at weeks 8 and 20 | Participants will be asked to perform a leg extension endurance exercise with electrodes placed on their forehead and thigh. | Change from 8 weeks and 20 weeks | |
Secondary | Brain tissue oxygenation tested at weeks 8 and 20 | 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. | Change from 8 weeks and 20 weeks |
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