Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- C-reactive Protein
研究概览
简要总结
This proposal will examine whether daily consumption of fermented vegetables for 6 weeks can impact the gut microflora and markers of inflammation of women between the ages of 18-70 years.
详细描述
Interested participants will be invited to an orientation where study procedures will be explained in detail. Once the consent form is signed participants will schedule a visit to provide blood, urine and stool samples at the beginning of the intervention at which point they will be randomized into one of three groups: a fermented vegetable group (1/2 cup per day for 6 weeks), a non-fermented vegetable group (1/2 cup per day for 6 weeks) and a control group (usual diet). Both vegetable groups will receive weekly deliveries of the vegetables to be consumed. Following 6 weeks, participants will provide blood, urine and stool samples one more time. Participants will also fill out questionnaires related to dietary intake, demographics, physical activity, prescription medication use and gastrointestinal function. Compliance will be monitored weekly via a gastrointestinal function log where participants will be asked to enter whether they consumed or not the vegetable provided each day, as well as any side effects of consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The study investigators will be blinded to the treatment conditions and the outcome assessors will only have access to study ID numbers when conducting the lab analyses.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI: 18.5-40 kg/m2
- •Non-smoker
- •No previous diagnosis of cancer
- •No thyroid disease
- •No diabetes
- •Willing to consume 1/2 cup of vegetables daily for 6 weeks
- •No use of psychotic or depression medication
- •No medication to lose weight
- •Not on a weight loss diet
- •No use of antibiotics over the past 3 months
- •No consumption of fermented vegetables on a regular basis
- •No history of autoimmune disease, including gastrointestinal disease
排除标准
- •BMI <18.5 or >40 kg/m2
- •Taking medications that affect appetite or body weight
- •Uncontrolled Hypertension
- •Not willing to consume 1/2 cup of vegetables daily for 6 weeks
- •Willing to show up at two appointments
- •Following a fad diet
- •Using antibiotics frequently
- •Diagnosed with autoimmune disease, like psoriasis, rheumatoid arthritis, thyroid disease, colitis
- •Regular consumption of fermented vegetables
结局指标
主要结局
C-reactive Protein
时间窗: 6 weeks
Marker of systemic inflammation: serum CRP
Shannon Index
时间窗: 6 weeks
The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.
次要结局
- Body Fat Percentage(6 weeks)
- Systolic Blood Pressure(6 weeks)
- Lipopolysaccharide(6 weeks)
- BMI(6 weeks)
研究者
Andrea Arikawa
Assistant Professor
University of North Florida