Gastrointestinal Microbiome, Inflammation, Women's Health
Conditions
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.
Interventions
OTHERFermented vegetable
The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks
OTHERNon-fermented vegetable
The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks
Sponsors
University of Arkansas
University of North Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes 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.
Intervention model description
This is a randomized parallel-arm trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive Protein | 6 weeks | Marker of systemic inflammation: serum CRP |
| Shannon Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 6 weeks | Measured using a multifrequency bioimpedance scale |
| Body Fat Percentage | 6 weeks | Measured using a multifrequency bioimpedance scale |
| Systolic Blood Pressure | 6 weeks | Measured using an electronic blood pressure cuff |
| Lipopolysaccharide | 6 weeks | Marker of inflammation in serum |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. | 10 |
| 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 | 11 |
| 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 | 13 |
| Total | 34 |
Baseline characteristics
| Characteristic | Control | Total | Non-fermented Vegetable | Fermented Vegetable |
|---|---|---|---|---|
| Age, Continuous | 27.5 years | 37 years | 44 years | 37 years |
| Education: Some college, College degree, Graduate degree College Degree | 5 Participants | 14 Participants | 6 Participants | 3 Participants |
| Education: Some college, College degree, Graduate degree Graduate Degree | 3 Participants | 14 Participants | 6 Participants | 5 Participants |
| Education: Some college, College degree, Graduate degree Some College | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 29 Participants | 12 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 24 Participants | 10 Participants | 8 Participants |
| Region of Enrollment United States | 10 participants | 34 participants | 13 participants | 11 participants |
| Sex: Female, Male Female | 10 Participants | 34 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 3 / 10 | 6 / 10 | 9 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 11 |
Outcome results
Primary
C-reactive Protein
Marker of systemic inflammation: serum CRP
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | C-reactive Protein | 160.7 ng/mL |
| Fermented Vegetable | C-reactive Protein | 173.4 ng/mL |
| Non-fermented Vegetable | C-reactive Protein | 211.4 ng/mL |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Shannon Index | 3.14 Shannon index |
| Fermented Vegetable | Shannon Index | 3.34 Shannon index |
| Non-fermented Vegetable | Shannon Index | 3.38 Shannon index |
Secondary
BMI
Measured using a multifrequency bioimpedance scale
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | BMI | 22.8 kg/m2 |
| Fermented Vegetable | BMI | 23.3 kg/m2 |
| Non-fermented Vegetable | BMI | 26.7 kg/m2 |
Secondary
Body Fat Percentage
Measured using a multifrequency bioimpedance scale
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Body Fat Percentage | 31.1 % body fat |
| Fermented Vegetable | Body Fat Percentage | 31.4 % body fat |
| Non-fermented Vegetable | Body Fat Percentage | 36.8 % body fat |
Secondary
Lipopolysaccharide
Marker of inflammation in serum
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Lipopolysaccharide | 12.7 micrograms/mL |
| Fermented Vegetable | Lipopolysaccharide | 12.7 micrograms/mL |
| Non-fermented Vegetable | Lipopolysaccharide | 13 micrograms/mL |
Secondary
Systolic Blood Pressure
Measured using an electronic blood pressure cuff
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Systolic Blood Pressure | 104 mmHg |
| Fermented Vegetable | Systolic Blood Pressure | 121 mmHg |
| Non-fermented Vegetable | Systolic Blood Pressure | 107 mmHg |