Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

NCT ID: NCT03407794

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-07
• Study Completion Date: 2021-04-16

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.

Conditions

Inflammation; Women's Health; Gastrointestinal Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Fermented vegetable

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

Non-fermented vegetable

Intervention Type: OTHER

The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks

Interventions

Fermented vegetable

The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks

Intervention Type: OTHER

Non-fermented vegetable

The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: collaborator

University of North Florida

OTHER

Sponsor Role: lead

Responsible Party

Andrea Arikawa

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of North Florida

Jacksonville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21745625 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25688926 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

10334264-2

Identifier Type: -

Identifier Source: org_study_id