Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

Inflammation Clinical Trial

Official title:

Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407794
• Other study ID #: 10334264-2
• Status: Completed
• Phase: N/A
• Start date: January 7, 2018
• Est. completion date: April 16, 2021

Study information

• Verified date: November 2022
• Source: University of North Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 16, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome
• Inflammation
• Women's Health

Intervention

Other:
• Fermented vegetable
The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks
• Non-fermented vegetable
The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks

Locations

Country	Name	City	State
United States	University of North Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of North Florida	University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive Protein	Marker of systemic inflammation: serum CRP	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.	6 weeks
Secondary	BMI	Measured using a multifrequency bioimpedance scale	6 weeks
Secondary	Body Fat Percentage	Measured using a multifrequency bioimpedance scale	6 weeks
Secondary	Systolic Blood Pressure	Measured using an electronic blood pressure cuff	6 weeks
Secondary	Lipopolysaccharide	Marker of inflammation in serum	6 weeks