Happy Gut Study - Fermented Vegetables and Cardiovascular Biomarkers
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Participants will also be sent information on how to fill out online questionnaires and they
      will be asked to complete the questionnaires prior to their clinic visit. The questionnaires
      will ask about demographic information, medical history, diet history and physical activity.
      The study website will contain all the data collection materials, so that enrolled
      participants can easily access these documents. Every randomized participant will receive a
      password to the website to access the study's materials.

      Procedures during each clinic visit The two clinic visits will take approximately 45 minutes,
      each and they will be scheduled in the morning hours, because participants will have to fast
      for 12-hours to provide blood samples. Participants will be greeted by study staff and their
      temperature will be checked as part of the covid screening. Then, they will be taken to the
      body composition assessment lab, for measurement of weight, height, and body fat % using the
      InBody 570. Participants will be asked to stand on a platform and hold on to the handles of
      the equipment for approximately 2 minutes for the assessment of body composition. Next,
      participants' blood pressure will be measured twice using a digital blood pressure monitor
      and they will be asked to recall their food consumption over the past 24 hours(24-hr diet
      recall). Lastly, trained nurses will collect approximately 16 mL of blood in two tubes.

      At the first clinic visit, participants randomized into the treatment group will receive
      print materials about a heart-healthy diet and a four-week supply of fermented vegetables
      with a measuring cup for easy portioning of the vegetables. They will also be asked to fill
      out an electronic symptoms log where they will list any side effects associated with food
      consumption, weekly. Participants randomized to the control group will only receive print
      materials about a heart-healthy diet, but they will also be asked to fill out the symptoms
      log.

      Following the first clinic visit, participants will be contacted by study staff once a week
      by phone or text-message, depending on their preferred method of contact. The weekly checks
      will serve to remind participants to fill out the symptoms log and to check on compliance in
      the case of the treatment group, by asking participants if they skipped any days or consumed
      less vegetables than prescribed for the week. At four weeks, all participants will be asked
      to provide another 24-hr diet recall, and another four-week supply of fermented vegetables
      will be delivered to participants in the treatment group.

      Data collection All questionnaire data will be filled out electronically with the exception
      of the three 24-hr recalls that will be done in person or by phone. All questionnaire data
      will be identified with a unique ID number that will be assigned to each participant. There
      will be only one file that will include participants' name with ID numbers, which will be
      password protected and stored in a secured drive.
    

Intervention name(s): Fermented vegetable
Intervention type(s): Other
Intervention description(s): Participants will be asked to consume 100 g of fermented vegetables per day, at least 5 days per week, for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: C-reactive protein; lipopolysaccharide binding protein; trimethylamine oxide; Oxidized LDL receptor