An interventional study of Fermented vegetable and Non-fermented vegetable in Inflammation, Women's Health and Gastrointestinal Microbiome, sponsored by University of North Florida. Completed at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by University of North Florida · Not applicable, Interventional, and Prevention
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.
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 34 is below the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of North Florida is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.
Other: Fermented vegetable
Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks.
Other: Non-fermented vegetable
The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks
The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks
C-reactive Protein
Marker of systemic inflammation: serum CRP
Time frame: 6 weeks
Shannon Index
The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.
Time frame: 6 weeks
BMI
Measured using a multifrequency bioimpedance scale
Time frame: 6 weeks
Body Fat Percentage
Measured using a multifrequency bioimpedance scale
Time frame: 6 weeks
Systolic Blood Pressure
Measured using an electronic blood pressure cuff
Time frame: 6 weeks
Lipopolysaccharide
Marker of inflammation in serum
Time frame: 6 weeks
| Milestone | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| Started | 10 | 11 | 13 |
| Completed | 10 | 10 | 11 |
| Not completed | 0 | 1 | 2 |
Marker of systemic inflammation: serum CRP
| ng/mL | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| C-reactive Protein | 160.7 (0 to 746) | 173.4 (0 to 375) | 211.4 (0 to 228) |
The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.
| Shannon index | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| Shannon Index | 3.14 (3.0 to 3.5) | 3.34 (3.3 to 3.7) | 3.38 (3.2 to 3.58) |
Measured using a multifrequency bioimpedance scale
| kg/m2 | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| BMI | 22.8 (22 to 28) | 23.3 (22 to 28) | 26.7 (22.5 to 27.2) |
Measured using a multifrequency bioimpedance scale
| % body fat | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| Body Fat Percentage | 31.1 (25 to 35.5) | 31.4 (22 to 41) | 36.8 (34.8 to 39.5) |
Measured using an electronic blood pressure cuff
| mmHg | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| Systolic Blood Pressure | 104 (89 to 111) | 121 (108 to 122) | 107 (104 to 121) |
Marker of inflammation in serum
| micrograms/mL | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| Lipopolysaccharide | 12.7 (8.1 to 14.9) | 12.7 (10.5 to 16.5) | 13 (11 to 15.5) |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Fermented Vegetable | 0/10 (0%) | 0/10 (0%) | 6/10 (60%) |
| Non-fermented Vegetable | 0/11 (0%) | 0/11 (0%) | 9/11 (81.8%) |
| Event | Control | Fermented Vegetable | Non-fermented Vegetable |
|---|---|---|---|
| BloatingGastrointestinal disorders | 0/10 | 5/10 | 6/11 |
| DiarrheaGastrointestinal disorders | 1/10 | 0/10 | 1/11 |
| Nausea/VomitingGastrointestinal disorders | 1/10 | 0/10 | 1/11 |
| Abdominal PailGastrointestinal disorders | 1/10 | 1/10 | 0/11 |
| HeadacheGeneral disorders | 0/10 | 0/10 | 1/11 |
| Age, Continuous(years) | Control | Fermented Vegetable | Non-fermented Vegetable | Total |
|---|---|---|---|---|
| Median | 27.5 (21 to 50) | 37 (19 to 63) | 44 (18 to 69) | 37 (18 to 69) |
| Sex: Female, Male(Participants) | Control | Fermented Vegetable | Non-fermented Vegetable | Total |
|---|---|---|---|---|
| Female | 10 | 11 | 13 | 34 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Control | Fermented Vegetable | Non-fermented Vegetable | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 1 | 4 |
| Not Hispanic or Latino | 8 | 9 | 12 | 29 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Control | Fermented Vegetable | Non-fermented Vegetable | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 2 | 5 |
| White | 6 | 8 | 10 | 24 |
| More than one race | 2 | 1 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control | Fermented Vegetable | Non-fermented Vegetable | Total |
|---|---|---|---|---|
| United States | 10 | 11 | 13 | 34 |
| Education: Some college, College degree, Graduate degree(Participants) | Control | Fermented Vegetable | Non-fermented Vegetable | Total |
|---|---|---|---|---|
| Some College | 2 | 3 | 1 | 6 |
| College Degree | 5 | 3 | 6 | 14 |
| Graduate Degree | 3 | 5 | 6 | 14 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan at the moment.
Ran from Jan 2018 to primary completion in Aug 2020, 31 months.
Results were first posted in Jan 2023, 2 years 4 months after primary completion.
Of 877 non-industry interventional studies with no phase under Inflammation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 31 months is above that.
Counting every sponsor, half of 924 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of North Florida