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临床试验/NCT02512107
NCT02512107已完成不适用

The Effect of Juice Plus+ on the Microbiome, Intestinal Permeability and Inflammatory Status of Psychologically Stressed Individuals With High Body Mass Indices

University of Memphis2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Changes in intestinal microbiome composition induced by a fruit and vegetable supplement using 16S rRNA sequencing analysis

研究概览

简要总结

The purpose of this study is to determine if a dried fruit and vegetable supplement (Juice Plus+) can alter the gut microbiome and improve gut permeability and inflammatory levels in an obese, stressed population.

The microbiome and its component genes are long known as critical determinants of the nutritional value of the food we eat. Recently, it has become clear that the composition of this microbiome and its metabolites influences the host immune system, thereby altering host physiology. Both obesity and chronic stress have been shown to have an altered gut microbiome; both these conditions also lead to increased systemic inflammatory molecules that can lead to an increased risk for type 2 diabetes and other diseases caused by chronic inflammation.

Juice Plus+ consumed by an overweight population combined with an eight week exercise regime showed decreased markers of protein/lipid oxidation (ox-LDL), total lipid oxidation (TOS) and lowered systemic concentrations of the inflammatory cytokine, TNF-α. As systemic cytokines are altered by the composition of the gut microbiome, this study proposes to determine if this decrease in inflammation by Juice Plus+ is due to a change in the species composition and metabolism of the microbiome. This question is particularly relevant for populations with high inflammatory loads resulting from excess weight in addition to increased psychological stress.

The investigators propose to determine 1) how Juice Plus+ consumption alters the microbiome species composition and metabolism, 2) if there is an alteration in intestinal permeability with the consumption of Juice Plus+ and 3) do these alterations coincide with lower systemic markers of inflammation and oxidative stress among individuals who are psychologically stressed and overweight. The investigators will use a randomized, placebo-controlled design with a cohort of overweight, female, critical care health care professionals. Subjects will receive the supplements or placebo for sixteen weeks. At the end of 16 weeks, the cohort receiving the supplement will be randomized to also receive a meal replacement component or follow their normal diet for an additional 4 weeks. Stool and a fasting blood sample will be collected at the beginning of the study (baseline) and 8, 16 and 20 weeks later. At each time point, subjects will also consume a cocktail of glucose, mannitol and lactulose and a second blood draw performed to look at absorption of these molecules.

详细描述

An anticipated eighty critical care, female health care professionals will be recruited. This population has been shown to have a high occupational stress load and have increased risk for post-traumatic stress disorder (PTSD). The subjects will be premenopausal, overweight/obese (Body Mass Index -BMI : 25 - 40 kg/m2) and between the ages of 25-50 years.

Exclusion criteria include smoking of any sort, smokeless tobacco use, chronic or excessive alcohol consumption (>1 drink per day), pregnancy or lactation, recent surgery or illness, diabetes, heart disease, use of antibiotics or medications (other than medication deemed not to impact outcome measures in this protocol-medication use will be reviewed on a case by case basis by the principal investigator).

Health history, medication and dietary supplement questionnaires will be completed by all subjects to determine eligibility. A health and perceived stress questionnaire will also be completed at each sampling period. Characteristics of stool will also be recorded for the three days prior to sampling using the Bristol criteria.

All food and drink intake will be recorded for the 7-day period prior to providing the first sample (baseline). Subjects will repeat this procedure at each sampling period. During the initial recording period, subjects will be asked to consume foods that represent their usual diet, with no more than a combined 4 fruit and vegetable servings each day, and be instructed to attempt to mimic the same diet during the 7 day periods each sampling period.

Diet records will be analyzed using nutrition software and the data will be used for analysis purposes as needed. Subjects will be encouraged to consume their usual diet throughout the study period.

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
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Critical care health care professional
  • Premenopausal
  • Overweight or obese (BMI: 25-40 kg/m2)
  • Between the ages of 25-50

排除标准

  • Smoking,including smokeless tobacco
  • Chronic/excessive alcohol use
  • Pregnant or lactating
  • Recent surgery or illness
  • Heart disease
  • Use of antibiotics

结局指标

主要结局

Changes in intestinal microbiome composition induced by a fruit and vegetable supplement using 16S rRNA sequencing analysis

时间窗: 1 year

次要结局

  • Changes in intestinal permeability by biochemical analysis(1 year)
  • Changes in systemic inflammatory molecules by cytokine analysis(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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