Happy Gut Study - Fermented Vegetables and Cardiovascular Biomarkers

NCT04887662 | Completed

• 1 other identifier: 1712254-1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to determine whether regular consumption of fermented vegetables can decrease inflammation and change the types of bacteria that are normally present in the large intestine. Recent research studies have linked the gut bacteria to many disorders and conditions, such as obesity, cardiovascular disease, diabetes, etc. We also know that certain bacteria are considered probiotic bacteria because they contribute to a healthy gut, while others have been associated with inflammation and disease. Fermented foods may contain beneficial bacteria that may improve health in humans. However, there is a lack of research studies examining the effects of regular consumption of fermented foods on health. This study will help investigators better understand if regular consumption of fermented vegetables can improve inflammation and change the gut bacteria towards a more beneficial profile.

Conditions

Cardiovascular Diseases

Keywords

C-reactive protein; lipopolysaccharide binding protein; trimethylamine oxide; Oxidized LDL receptor

Outcome Measures

Primary Outcomes (5)

• Change in C-reactive protein

  ng/mL

  baseline and 8 weeks later

• Change in oxidized LDL receptor

  pg/mL

  baseline and 8 weeks later

• Change in trimethylamine oxide

  ng/mL

  baseline and 8 weeks later

• Change in lipopolysaccharide binding protein

  ng/mL

  baseline and 8 weeks later

• Change in Shannon Index

  no unit

  baseline and 8 weeks later

Secondary Outcomes (1)

• Change in angiopoietin-like protein 4

  baseline and 8 weeks later

Study Arms (2)

Control

NO INTERVENTION

The control group will be asked to follow their usual diet, but will receive print materials about a diet for cardiovascular health.

Fermented vegetable

EXPERIMENTAL

The fermented vegetable group will be asked to consume 100 g of fermented vegetables per day, at least 5 days per week for 8 weeks.

Other: Fermented vegetable

Interventions

Fermented vegetable OTHER

Participants will be asked to consume 100 g of fermented vegetables per day, at least 5 days per week, for 8 weeks

Fermented vegetable

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI over 25.9
• Generally healthy

You may not qualify if:

• Diabetes
• Taking statins
• Taking monoamine oxidase inhibitors
• Salt sensitivity
• Uncontrolled hypertension
• Diagnosed with Autoimmune disease
• Regular use of probiotics
• Regular use of antibiotics
• Pregnant or breastfeeding

Sponsors & Collaborators

• University of North Florida: lead

Study Sites (1)

University of North Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Study website

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 14, 2021
• Study Start: May 5, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)