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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented vegetable | Other | The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Measured using a multifrequency bioimpedance scale | 6 weeks |
| Body Fat Percentage | Measured using a multifrequency bioimpedance scale |
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Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is based on self-representation of gender identity
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21745625 | Background | 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. | |
| 25688926 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. |
| FG001 | 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. Fermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks |
| FG002 | 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. Non-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. |
| BG001 | 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. Fermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | C-reactive Protein | Marker of systemic inflammation: serum CRP | Posted | Median | Inter-Quartile Range | ng/mL | 6 weeks |
|
6 weeks
All study participants were healthy and no serious adverse events were expected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
This was a small pilot and feasibility study. There were few subjects in each group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Arikawa | University of North Florida | 9044798995 | andrea.arikawa@unf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2019 | Apr 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2019 | Sep 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a randomized parallel-arm trial
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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.
| Non-fermented vegetable | Other | The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks |
|
| 6 weeks |
| Systolic Blood Pressure | Measured using an electronic blood pressure cuff | 6 weeks |
| Lipopolysaccharide | Marker of inflammation in serum | 6 weeks |
| BG002 | 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. Non-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education: Some college, College degree, Graduate degree | Count of Participants | Participants |
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| 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. Non-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks |
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Shannon index | 6 weeks |
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| Secondary | BMI | Measured using a multifrequency bioimpedance scale | Posted | Median | Inter-Quartile Range | kg/m2 | 6 weeks |
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| Secondary | Body Fat Percentage | Measured using a multifrequency bioimpedance scale | Posted | Median | Inter-Quartile Range | % body fat | 6 weeks |
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|
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| Secondary | Systolic Blood Pressure | Measured using an electronic blood pressure cuff | Posted | Median | Inter-Quartile Range | mmHg | 6 weeks |
|
|
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| Secondary | Lipopolysaccharide | Marker of inflammation in serum | Posted | Median | Inter-Quartile Range | micrograms/mL | 6 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | 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. Fermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks | 0 | 10 | 0 | 10 | 6 | 10 |
| EG002 | 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. Non-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks | 0 | 11 | 0 | 11 | 9 | 11 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pail | Gastrointestinal disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
|
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