Mankowski R T, Leeuwenburgh C, Manini T M, Woods A J, Anton S D
Stephen D. Anton, PhD, 2004 Mowry Rd, PO Box 100107, Gainesville, FL 32611, Phone: 352-273-7514, Fax: 352-273-5920, E-mail:
J Frailty Aging. 2018;7(2):142-146. doi: 10.14283/jfa.2018.6.
Fermented Papaya Preparation (FPP®) has shown antioxidative and anti-inflammatory effects in preclinical and clinical aging studies. However, clinical trials are needed to fully evaluate the safety of FPP® in moderate-functioning, generally healthy older adults. In this randomized (9g/day of FPP® or placebo), crossover design study, we enrolled 30 older moderate-functioning older adults (70-100 years old). The participants completed both a treatment and a placebo condition. After eight (8) weeks on each of these regimens (with a 4-week wash-out period in between), participants had their venous blood drawn for assessment of blood chemistries, metabolic outcomes and inflammatory biomarkers. Participants were asked to report any adverse events during the course of the study and complete post-treatment outcome assessments for anthropometric and metabolic outcomes. The major finding related to safety was that there were no adverse changes in blood chemistries and few adverse events in the FPP® condition, which did not differ from placebo (p>0.05). There were no serious adverse effects in either condition. Twenty-nine (29) participants (mean age 78.2±5.3 yrs) completed the study with 94% adherence to the dosing regimen. There were no significant effects of FPP® on anthropometric and metabolic outcomes. In addition, no effects on markers of inflammation were observed. Our trial demonstrates FPP® supplementation is safe and feasible in adults ages 70 years and older. Based on these findings and the positive effects FPP has demonstrated in previous trials, future trials should examine the effects of FPP® in older adults with impaired health status and/or older adults who may have insufficient anti-oxidant protection due to their genetic background.
发酵木瓜制品（FPP®）在临床前和临床衰老研究中已显示出抗氧化和抗炎作用。然而，需要进行临床试验来全面评估FPP®在功能中等、总体健康的老年人中的安全性。在这项随机（每天9克FPP®或安慰剂）交叉设计研究中，我们招募了30名功能中等的老年人（70 - 100岁）。参与者完成了治疗和安慰剂两种情况。在每种方案进行八（8）周后（中间有4周的洗脱期），采集参与者的静脉血以评估血液化学指标、代谢结果和炎症生物标志物。要求参与者报告研究过程中的任何不良事件，并完成人体测量和代谢结果的治疗后结局评估。与安全性相关的主要发现是，FPP®组的血液化学指标没有不良变化，不良事件也很少，与安慰剂组无差异（p>0.05）。两种情况下均无严重不良反应。29名（平均年龄78.2±5.3岁）参与者完成了研究，对给药方案的依从性为94%。FPP®对人体测量和代谢结果没有显著影响。此外，未观察到对炎症标志物的影响。我们的试验表明，补充FPP®在70岁及以上成年人中是安全可行的。基于这些发现以及FPP在先前试验中已证明的积极作用，未来的试验应研究FPP®对健康状况受损的老年人和/或由于遗传背景可能抗氧化保护不足的老年人的影响。
