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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Women's Health; Gastrointestinal Microbiome
• Intervention / Treatment: Other: Fermented vegetable; Other: Non-fermented vegetable

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • University of North Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of North Florida
• Collaborators: University of Arkansas

Publications and helpful links

General Publications

• Kim EK, An SY, Lee MS, Kim TH, Lee HK, Hwang WS, Choe SJ, Kim TY, Han SJ, Kim HJ, Kim DJ, Lee KW. Fermented kimchi reduces body weight and improves metabolic parameters in overweight and obese patients. Nutr Res. 2011 Jun;31(6):436-43. doi: 10.1016/j.nutres.2011.05.011.
• Han K, Bose S, Wang JH, Kim BS, Kim MJ, Kim EJ, Kim H. Contrasting effects of fresh and fermented kimchi consumption on gut microbiota composition and gene expression related to metabolic syndrome in obese Korean women. Mol Nutr Food Res. 2015 May;59(5):1004-8. doi: 10.1002/mnfr.201400780. Epub 2015 Mar 23.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 10334264-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan at the moment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No