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临床试验/NCT02316925
NCT02316925撤回不适用

Oral Glutathione Supplementation on Cold/Flu Symptoms in Older Healthy Adults

University of Florida0 个研究点开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Severity and frequency of Cold / Flu symptoms

研究概览

简要总结

A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs. The primary end point is the number of healthy days experienced during cold and flu season. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.

详细描述

The long term goal of this investigation is to understand how food components improve immune function, both in its ability to respond to pathogens and its ability to turn off when the response is no longer needed. The goal of this application is to examine mechanisms by which glutathione improves immune cells after consumption. The central hypothesis is that glutathione improves redox status within the cell, thereby improving cell function and increasing the number of healthy days experienced by the participants.

After obtaining informed consent, human participants will receive 500 mg/day of Setria® Glutathione or placebo for 120 days. Peripheral blood mononuclear cells (PBMC), neutrophils and serum will be obtained from blood draws before and after the 120 days. A daily diary of illness will be kept by each participant and will record any incidence of illness, the number of symptoms per incidence, and the number of days in which symptoms are present. This study is powered on the basis that over 120 days, the glutathione-supplemented group would experience 3% more healthy days compared to the placebo group. The analysis indicated 60 people per group. Timeline should be between mid-January to May because the Center for Disease Control and Prevention indicates that this is the cold and flu season (http://www.cdc.gov/flu/weekly/fluactivity.htm) in the southwest part of the country.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • generally healthy
  • must have had at least one cold during the previous year
  • age 50-75
  • must discontinue other dietary supplement use

排除标准

  • on arthritis medication
  • on hypertension medication
  • severe allergies
  • compromised immune system
  • high cholesterol, heart failure, angina, etc.
  • diagnoses of diabetes or metabolic syndrome

结局指标

主要结局

Severity and frequency of Cold / Flu symptoms

时间窗: 120 days

Participants will record any cold / flu symptoms in log throughout the study duration

次要结局

  • Improvement of immune cell function(120 days)

研究者

申办方类型
Other
责任方
Sponsor

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