The Effects of Regular Consumption of Fermented Vegetables on the Gut Bacteria and Markers Associated With Cardiovascular Disease in Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Change in Shannon Index
研究概览
简要总结
The purpose of this project is to determine whether regular consumption of fermented vegetables can decrease inflammation and change the types of bacteria that are normally present in the large intestine. Recent research studies have linked the gut bacteria to many disorders and conditions, such as obesity, cardiovascular disease, diabetes, etc. We also know that certain bacteria are considered probiotic bacteria because they contribute to a healthy gut, while others have been associated with inflammation and disease. Fermented foods may contain beneficial bacteria that may improve health in humans. However, there is a lack of research studies examining the effects of regular consumption of fermented foods on health. This study will help investigators better understand if regular consumption of fermented vegetables can improve inflammation and change the gut bacteria towards a more beneficial profile.
详细描述
Investigators will recruit 90-100 participants for this study. Participants will be recruited by posting flyers throughout Jacksonville, social media advertisements, and by advertisements on public radio. Recruitment flyers and advertisements will direct potential participants to email or call study staff or visit the study website. The study website will direct potential participants to answer the screening questions and those found to be eligible will be asked to provide contact information so that study staff can contact them to schedule an orientation via zoom. The study orientation will last approximately 45 minutes and will include a PowerPoint presentation about the study, outlining all procedures and a thorough review of the consent form.
After the study orientation, participants will be given two weeks to contact the study if they wish to participate. Those who decide to participate will be asked to schedule their baseline appointment by calling or emailing the study. During the initial appointment, participants will be asked to sign a copy of the consent form and any additional questions they might have about the study will be answered. Both the baseline and follow up visits will take place in building 39/39A, 3rd floor. The time frame between the orientation and the baseline appointment will range between 2 and 3 weeks.
Procedures prior to each clinic visit
There will be a total of two clinic visits, and the same procedures apply to both:
Once participants schedule their first visit, they will be mailed a stool collection kit containing three collection tubes, a collection hat, and a liner for the collection hat, along with instructions on how to collect the stool samples. These instructions will also be available on the study's website. These samples will be collected prior to the first clinic visit, so that participants can bring the collection tubes with them to the clinic visit.
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
- None
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI over 25.9
- •Generally healthy
排除标准
- •Taking statins
- •Taking monoamine oxidase inhibitors
- •Salt sensitivity
- •Uncontrolled hypertension
- •Diagnosed with Autoimmune disease
- •Regular use of probiotics
- •Regular use of antibiotics
- •Pregnant or breastfeeding
结局指标
主要结局
Change in Shannon Index
时间窗: baseline and 8 weeks later
no unit
Change in trimethylamine oxide
时间窗: baseline and 8 weeks later
ng/mL
Change in lipopolysaccharide binding protein
时间窗: baseline and 8 weeks later
ng/mL
Change in C-reactive protein
时间窗: baseline and 8 weeks later
ng/mL
Change in oxidized LDL receptor
时间窗: baseline and 8 weeks later
pg/mL
次要结局
- Change in angiopoietin-like protein 4(baseline and 8 weeks later)