Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

University of North Florida34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Inflammation Women's Health Gastrointestinal Microbiome

Interventions

Fermented vegetableOTHER

The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks

Non-fermented vegetableOTHER

The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of North Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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