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Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

Primary Purpose

Inflammation, Women's Health, Gastrointestinal Microbiome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fermented vegetable
Non-fermented vegetable
Sponsored by
University of North Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Control

Fermented vegetable

Non-fermented vegetable

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

C-reactive Protein
Marker of systemic inflammation: serum CRP
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.

Secondary Outcome Measures

BMI
Measured using a multifrequency bioimpedance scale
Body Fat Percentage
Measured using a multifrequency bioimpedance scale
Systolic Blood Pressure
Measured using an electronic blood pressure cuff
Lipopolysaccharide
Marker of inflammation in serum

Full Information

First Posted
January 16, 2018
Last Updated
November 28, 2022
Sponsor
University of North Florida
Collaborators
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT03407794
Brief Title
Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women
Official Title
Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
April 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Florida
Collaborators
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Women's Health, Gastrointestinal Microbiome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized parallel-arm trial
Masking
InvestigatorOutcomes Assessor
Masking Description
The study investigators will be blinded to the treatment conditions and the outcome assessors will only have access to study ID numbers when conducting the lab analyses.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
Arm Title
Fermented vegetable
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-fermented vegetable
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fermented vegetable
Intervention Description
The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks
Intervention Type
Other
Intervention Name(s)
Non-fermented vegetable
Intervention Description
The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks
Primary Outcome Measure Information:
Title
C-reactive Protein
Description
Marker of systemic inflammation: serum CRP
Time Frame
6 weeks
Title
Shannon Index
Description
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 Outcome Measure Information:
Title
BMI
Description
Measured using a multifrequency bioimpedance scale
Time Frame
6 weeks
Title
Body Fat Percentage
Description
Measured using a multifrequency bioimpedance scale
Time Frame
6 weeks
Title
Systolic Blood Pressure
Description
Measured using an electronic blood pressure cuff
Time Frame
6 weeks
Title
Lipopolysaccharide
Description
Marker of inflammation in serum
Time Frame
6 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 <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
Facility Information:
Facility Name
University of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan at the moment.
Citations:
PubMed Identifier
21745625
Citation
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.
Results Reference
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PubMed Identifier
25688926
Citation
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.
Results Reference
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Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

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