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
| Type | Name | Description |
|---|---|---|
| OTHER | Fermented vegetable | The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks |
| OTHER | Non-fermented vegetable | The 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.