InflammationNCT03407794
Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women
A study testing Fermented vegetable and Non-fermented vegetable in people with Inflammation and Women's Health, run by University of North Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Women's Health, Gastrointestinal Microbiome
- What is being tested?
- Fermented vegetable and Non-fermented vegetable
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2018to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Florida
Jacksonville, Florida, 32224
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammation, Women's Health, Gastrointestinal Microbiome
- Being tested
- Fermented vegetable, Non-fermented vegetable
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. |
| Fermented vegetable | Experimental | 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. Receives: Other: Fermented vegetable |
| Non-fermented vegetable | Active comparator | 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. Receives: Other: Non-fermented vegetable |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive Protein
Marker of systemic inflammation: serum CRP
Measured: 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.
Measured: 6 weeks
Secondary outcomes (4)
BMI
Measured using a multifrequency bioimpedance scale
Measured: 6 weeks
Body Fat Percentage
Measured using a multifrequency bioimpedance scale
Measured: 6 weeks
Systolic Blood Pressure
Measured using an electronic blood pressure cuff
Measured: 6 weeks
Lipopolysaccharide
Marker of inflammation in serum
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start7 Jan 2018
- Primary completion31 Aug 2020
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized parallel-arm trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Andrea Arikawa, University of North Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407794
- Sponsor's protocol ID
- 10334264-2
- Status last verified
- Nov 2022
- First submitted
- 16 Jan 2018
- Last updated
- 11 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan at the moment.
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.
PubMed 21745625Han 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.
PubMed 25688926
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT03407794
- Acronym / sponsor ID
- 10334264-2
- Conditions
- Inflammation, Women's Health, Gastrointestinal Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of North FloridaUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 11 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized parallel-arm trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. |
| Fermented vegetable | Experimental | Other: Fermented vegetableParticipants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks. |
| Non-fermented vegetable | Active comparator | Other: Non-fermented vegetableParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- BMI: 18.5-40 kg/m2
- Non-smoker
- No previous diagnosis of cancer
- No thyroid disease
- No diabetes
Key exclusion criteria (11 listed)
- BMI <18.5 or >40 kg/m2
- Smoker
- Taking medications that affect appetite or body weight
- Uncontrolled Hypertension
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented vegetableThe intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks | Other | Fermented vegetable |
| Non-fermented vegetableThe intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks | Other | Non-fermented vegetable |
Primary outcome
C-reactive Protein
Time frame: 6 weeks
Marker of systemic inflammation: serum CRP
Shannon Index
Time frame: 6 weeks
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.
4 secondary outcomes
BMI
Time frame: 6 weeks
Body Fat Percentage
Time frame: 6 weeks
Systolic Blood Pressure
Time frame: 6 weeks
Lipopolysaccharide
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21745625Kim 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.
- Background: PubMed 25688926Han 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.
- Individual participant dataSharing planned: No. There is no plan at the moment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented vegetable and Non-fermented vegetable in people with Inflammation and Women's Health, run by University of North Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive Protein (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407794, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.