Clinical trial NCT03407794: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Women's Health
Gastrointestinal Microbiome
Lead sponsor: University of North Florida
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2018-01-23
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized parallel-arm trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: C-reactive Protein
timeFrame: 6 weeks
measure: Shannon Index
timeFrame: 6 weeks
Secondary outcomes:
measure: BMI
timeFrame: 6 weeks
measure: Body Fat Percentage
timeFrame: 6 weeks
measure: Systolic Blood Pressure
timeFrame: 6 weeks
measure: Lipopolysaccharide
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of North Florida
state: Florida
Study officials:
References:
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.
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.