CompletedNot Applicable

Happy Gut Study - Fermented Vegetables and Cardiovascular Biomarkers

United States87 participantsStarted 2021-05-05

Plain-language 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.

Who can participate

Age range

35 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BMI over 25.9 * Generally healthy Exclusion Criteria: * Diabetes * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in C-reactive protein

Timeframe: baseline and 8 weeks later

Change in oxidized LDL receptor

Timeframe: baseline and 8 weeks later

Change in trimethylamine oxide

Timeframe: baseline and 8 weeks later

Change in lipopolysaccharide binding protein

Timeframe: baseline and 8 weeks later

Change in Shannon Index

Timeframe: baseline and 8 weeks later

Trial details

NCT IDNCT04887662

SponsorUniversity of North Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-06

View on ClinicalTrials.gov More Cardiovascular Diseases trials

Plain-language summary

Who can participate

Age range

35 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in C-reactive protein

Timeframe: baseline and 8 weeks later

Change in oxidized LDL receptor

Timeframe: baseline and 8 weeks later

Change in trimethylamine oxide

Timeframe: baseline and 8 weeks later

Change in lipopolysaccharide binding protein

Timeframe: baseline and 8 weeks later

Change in Shannon Index

Timeframe: baseline and 8 weeks later