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Completed

NCT Number: NCT03407794

Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented vegetable

Other

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

Non-fermented vegetable

Other

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

Primary outcomes

  1. C-reactive Protein

    Time frame: 6 weeks

    Marker of systemic inflammation: serum CRP

  2. Shannon Index

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. BMI

    Time frame: 6 weeks

    Measured using a multifrequency bioimpedance scale

  2. Body Fat Percentage

    Time frame: 6 weeks

    Measured using a multifrequency bioimpedance scale

  3. Systolic Blood Pressure

    Time frame: 6 weeks

    Measured using an electronic blood pressure cuff

  4. Lipopolysaccharide

    Time frame: 6 weeks

    Marker of inflammation in serum

Sponsors and collaborators

Lead sponsor

University of North Florida

Other

Collaborators

  • University of Arkansas

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 23, 2018
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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