Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women

University of North Florida

Status: Completed

Conditions: Inflammation; Women's Health; Gastrointestinal Microbiome

Treatments: Other: Fermented vegetable; Other: Non-fermented vegetable

Study type: Interventional

Funder types: Other

Identifiers

NCT03407794

10334264-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

34 participants in 3 patient groups

Control

No Intervention group

Description:

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

Fermented vegetable

Experimental group

Description:

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.

Treatment:

Other: Fermented vegetable

Non-fermented vegetable

Active Comparator group

Description:

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.

Treatment:

Other: Non-fermented vegetable