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临床试验/NCT05191758
NCT05191758已完成不适用

Nutritional Regulation of Leukocyte Function

Indiana University2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation

研究概览

简要总结

The objective of the current study is to determine the dose at which Fermented Papaya Preparation ( FPP) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.

详细描述

Fermented Papaya Preparation (FPP) is a dietary supplement that is available as over-the-counter in the US. FPP possesses antioxidant properties, which provide benefit against age-related complications[]. Chronic wounds in patients with diabetes represent a major public health problem. Previous studies from the investigators have demonstrated that wound-site macrophages from patients with diabetes are compromised in their ability to support wound healing. Several independent observations convergently point toward the hypothesis that treatment with papaya preparations may facilitate wound healing responses. Our laboratory reported the first evidence demonstrating that FPP may improve diabetic wound outcomes by specifically influencing the response of wound-site macrophages and the subsequent angiogenic response. FPP has a long track record of safe human consumption. The objective of the current study is to determine the dose at which FPP is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (PBMC) and neutrophils of participants. Our investigators have reported that supplementation with standardized fermented papaya preparation (FPP) in mice improves dermal wound healing outcomes. Therefore, based on these observations, the investigators propose to study the dose at which FPP supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 and above
  • Subjects must be able to follow directions and give informed consent on their own

排除标准

  • • Individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. Informed consent will be excluded.
  • Females who are pregnant will also be excluded to minimize the risk to such individuals (and fetus).
  • Individuals who are therapeutically immuno-compromised will also be excluded to decrease statistical variability and to minimize potential of confounders.
  • Candidates for inclusion into the study will not include individuals as defined in 45 CFR 46 Subparts B, C and D, nor from any other population which may be considered vulnerable.

结局指标

主要结局

Reactive Oxygen species (ROS) production of Leucocytes 6 weeks post supplementation

时间窗: 6 weeks post supplementation

The major objectives of the study is to study the mechanism of action on ROS production by leucocytes of healthy subjects post 6 weeks FPP supplementation measured by flowcytometry

Blood leukocyte phagocytosis 6 weeks post supplementation

时间窗: 6 weeks post supplementation

Blood leukocyte phagocytosis 6 weeks post supplementation via cell biology technique

次要结局

  • Leukocyte activation and cytokine production at 6 wks post supplementation(5 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sashwati Roy

Professor of Surgery

Indiana University

研究点 (2)

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