Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

NCT03407794 | Completed Results

• 1 other identifier: 10334264-2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Women's Health; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (2)

• C-reactive Protein

  Marker of systemic inflammation: serum CRP

  6 weeks

• 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 Outcomes (4)

• BMI

  6 weeks

• Body Fat Percentage

  6 weeks

• Systolic Blood Pressure

  6 weeks

• Lipopolysaccharide

  6 weeks

Study Arms (3)

Control

NO INTERVENTION

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

Fermented vegetable

EXPERIMENTAL

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

Non-fermented vegetable

ACTIVE COMPARATOR

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

Interventions

Fermented vegetable OTHER

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

Fermented vegetable

Non-fermented vegetable OTHER

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

Non-fermented vegetable

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Florida: lead
• University of Arkansas: collaborator

Study Sites (1)

University of North Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (2)

• 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.

  PMID: 21745625 BACKGROUND

• 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.

  PMID: 25688926 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a small pilot and feasibility study. There were few subjects in each group.

Results Point of Contact

• Title: Andrea Arikawa
• Organization: University of North Florida

andrea.arikawa@unf.edu

9044798995

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a randomized parallel-arm trial

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: January 7, 2018
• Primary Completion: August 31, 2020
• Study Completion: April 16, 2021
• Last Updated: January 11, 2023
• Results First Posted: January 11, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)