Clinical Trials Directory

Trials / Completed

CompletedNCT03407794

Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
University of North Florida · Academic / Other
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERFermented vegetableThe intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks
OTHERNon-fermented vegetableThe intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks

Timeline

Start date
2018-01-07
Primary completion
2020-08-31
Completion
2021-04-16
First posted
2018-01-23
Last updated
2023-01-11
Results posted
2023-01-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03407794. Inclusion in this directory is not an endorsement.