Trial Outcomes & Findings for Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women (NCT NCT03407794)
NCT ID: NCT03407794
Last Updated: 2023-01-11
Results Overview
Marker of systemic inflammation: serum CRP
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-01-11
Participant Flow
Participant milestones
| Measure |
Control
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
13
|
|
Overall Study
COMPLETED
|
10
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women
Baseline characteristics by cohort
| Measure |
Control
n=10 Participants
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=11 Participants
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
|
Non-fermented Vegetable
n=13 Participants
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
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
27.5 years
n=99 Participants
|
37 years
n=107 Participants
|
44 years
n=206 Participants
|
37 years
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
13 participants
n=206 Participants
|
34 participants
n=7 Participants
|
|
Education: Some college, College degree, Graduate degree
Some College
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Education: Some college, College degree, Graduate degree
College Degree
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Education: Some college, College degree, Graduate degree
Graduate Degree
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 weeksMarker of systemic inflammation: serum CRP
Outcome measures
| Measure |
Control
n=10 Participants
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=11 Participants
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
|
Non-fermented Vegetable
n=10 Participants
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
|
|---|---|---|---|
|
C-reactive Protein
|
160.7 ng/mL
Interval 0.0 to 746.0
|
173.4 ng/mL
Interval 0.0 to 375.0
|
211.4 ng/mL
Interval 0.0 to 228.0
|
PRIMARY outcome
Timeframe: 6 weeksThe 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.
Outcome measures
| Measure |
Control
n=9 Participants
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=10 Participants
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
|
Non-fermented Vegetable
n=11 Participants
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
|
|---|---|---|---|
|
Shannon Index
|
3.14 Shannon index
Interval 3.0 to 3.5
|
3.34 Shannon index
Interval 3.3 to 3.7
|
3.38 Shannon index
Interval 3.2 to 3.58
|
SECONDARY outcome
Timeframe: 6 weeksMeasured using a multifrequency bioimpedance scale
Outcome measures
| Measure |
Control
n=10 Participants
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=10 Participants
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
|
Non-fermented Vegetable
n=11 Participants
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
|
|---|---|---|---|
|
BMI
|
22.8 kg/m2
Interval 22.0 to 28.0
|
23.3 kg/m2
Interval 22.0 to 28.0
|
26.7 kg/m2
Interval 22.5 to 27.2
|
SECONDARY outcome
Timeframe: 6 weeksMeasured using a multifrequency bioimpedance scale
Outcome measures
| Measure |
Control
n=10 Participants
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=10 Participants
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
|
Non-fermented Vegetable
n=11 Participants
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
|
|---|---|---|---|
|
Body Fat Percentage
|
31.1 % body fat
Interval 25.0 to 35.5
|
31.4 % body fat
Interval 22.0 to 41.0
|
36.8 % body fat
Interval 34.8 to 39.5
|
SECONDARY outcome
Timeframe: 6 weeksMeasured using an electronic blood pressure cuff
Outcome measures
| Measure |
Control
n=10 Participants
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=10 Participants
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
|
Non-fermented Vegetable
n=11 Participants
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
|
|---|---|---|---|
|
Systolic Blood Pressure
|
104 mmHg
Interval 89.0 to 111.0
|
121 mmHg
Interval 108.0 to 122.0
|
107 mmHg
Interval 104.0 to 121.0
|
SECONDARY outcome
Timeframe: 6 weeksMarker of inflammation in serum
Outcome measures
| Measure |
Control
n=10 Participants
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=10 Participants
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
|
Non-fermented Vegetable
n=11 Participants
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
|
|---|---|---|---|
|
Lipopolysaccharide
|
12.7 micrograms/mL
Interval 8.1 to 14.9
|
12.7 micrograms/mL
Interval 10.5 to 16.5
|
13 micrograms/mL
Interval 11.0 to 15.5
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fermented Vegetable
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Non-fermented Vegetable
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=10 participants at risk
Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
|
Fermented Vegetable
n=10 participants at risk
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
|
Non-fermented Vegetable
n=11 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/10 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
50.0%
5/10 • Number of events 20 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
54.5%
6/11 • Number of events 17 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
0.00%
0/10 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
9.1%
1/11 • Number of events 3 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
10.0%
1/10 • Number of events 2 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
0.00%
0/10 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
9.1%
1/11 • Number of events 2 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
|
Gastrointestinal disorders
Abdominal Pail
|
10.0%
1/10 • Number of events 10 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
10.0%
1/10 • Number of events 4 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
0.00%
0/11 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
|
General disorders
Headache
|
0.00%
0/10 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
0.00%
0/10 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
9.1%
1/11 • Number of events 2 • 6 weeks
All study participants were healthy and no serious adverse events were expected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place