Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

• Sponsor: University of North Florida (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03407794
• Collaborator: University of Arkansas (Other)
• Enrollment: 34
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 31.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Women's Health; Gastrointestinal Microbiome	Other: Fermented vegetable; Other: Non-fermented vegetable	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a randomized parallel-arm trialThis is a randomized parallel-arm trial
• 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.
• Primary Purpose: Prevention
• Official Title: Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women
• Actual Study Start Date: Jan 7, 2018
• Anticipated Primary Completion Date: Aug 31, 2020
• Anticipated Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.
Experimental: 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.	Other: Fermented vegetable; The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks
Active Comparator: 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.	Other: Non-fermented vegetable; The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks

Outcome Measures

Primary Outcome Measures

1. Insulin [6 weeks]

   Serum insulin

2. C-reactive protein [6 weeks]

   Marker of systemic inflammation: serum CRP

3. Composition of the gut microflora [6 weeks]

   stool profile of gut microflora

Secondary Outcome Measures

1. Body weight [6 weeks]

   Measured using a multifrequency bioimpedance scale

2. Body fat percentage [6 weeks]

   Measured using a bioimpedance scale

3. Systolic and diastolic blood pressure [6 weeks]

   Measured using an electronic blood pressure cuff

4. BMI [6 weeks]

   Measured as weight (kg)/height (m)^2

5. Lipopolysaccharide [6 weeks]

   Marker of inflammation in serum

6. F2-isoprostanes [6 weeks]

   Marker of oxidative stress/inflammation in urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• University of North Florida
• University of Arkansas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Andrea Arikawa, Assistant Professor, University of North Florida
• ClinicalTrials.gov Identifier: NCT03407794
• Other Study ID Numbers: 10334264-2
• First Posted: Jan 23, 2018
• Last Update Posted: Apr 8, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Apr 8, 2020