Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation, Women's Health, Gastrointestinal Microbiome

Intervention / Treatment
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* Other: Fermented vegetable
* Other: Non-fermented vegetable


Participation Criteria
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Eligibility Criteria
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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 <18.5 or >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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized parallel-arm trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. | |
| Experimental: Fermented vegetable<br>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<br>* The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks<br>|
| Active Comparator: Non-fermented vegetable<br>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<br>* The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive Protein | Marker of systemic inflammation: serum CRP | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Measured using a multifrequency bioimpedance scale | 6 weeks | 
| Body Fat Percentage | Measured using a multifrequency bioimpedance scale | 6 weeks | 
| Systolic Blood Pressure | Measured using an electronic blood pressure cuff | 6 weeks | 
| Lipopolysaccharide | Marker of inflammation in serum | 6 weeks |