N/A
N=34
Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women
Inflammation · Women's Health · Gastrointestinal Microbiome
Bottom Line
View on ClinicalTrials.gov: NCT03407794 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: C-reactive Protein — 160.7; 173.4; 211.4 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fermented vegetable (Other); Non-fermented vegetable (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Florida
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C-reactive Protein |
160.7; 173.4; 211.4 | — |
| PRIMARY Shannon Index |
3.14; 3.34; 3.38 | — |
| SECONDARY BMI |
22.8; 23.3; 26.7 | — |
| SECONDARY Body Fat Percentage |
31.1; 31.4; 36.8 | — |
| SECONDARY Systolic Blood Pressure |
104; 121; 107 | — |
| SECONDARY Lipopolysaccharide |
12.7; 12.7; 13 | — |
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.
Eligibility Criteria
Inclusion Criteria
- BMI: 18.5-40 kg/m2
- Non-smoker
- No previous diagnosis of cancer
- No thyroid disease
- No diabetes
- Willing to consume 1/2 cup of vegetables daily for 6 weeks
- No use of psychotic or depression medication
- No medication to lose weight
- Not on a weight loss diet
- No use of antibiotics over the past 3 months
- No consumption of fermented vegetables on a regular basis
- No history of autoimmune disease, including gastrointestinal disease
Exclusion Criteria
- BMI 40 kg/m2
- Smoker
- Taking medications that affect appetite or body weight
- Uncontrolled Hypertension
- Diabetes
- Not willing to consume 1/2 cup of vegetables daily for 6 weeks
- Willing to show up at two appointments
- Following a fad diet
- Using antibiotics frequently
- Diagnosed with autoimmune disease, like psoriasis, rheumatoid arthritis, thyroid disease, colitis
- Regular consumption of fermented vegetables
Data sourced from ClinicalTrials.gov (NCT03407794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.