Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/5/2018 |
| Start Date: | January 7, 2018 |
| End Date: | August 31, 2019 |
| Contact: | Andrea Y Arikawa, PhD |
| Email: | andrea.arikawa@unf.edu |
| Phone: | 904-620-1433 |
Effects of Fermented Vegetables on Markers of Inflammation and Composition of the Intestinal Microflora in Overweight and Obese Women
Overweight and obese individuals seem to have an altered profile of the gut microflora
compared to normal weight individuals. This proposal will examine whether daily consumption
of fermented vegetables for 6 weeks can impact the gut microflora and markers of inflammation
of overweight and obese women.
compared to normal weight individuals. This proposal will examine whether daily consumption
of fermented vegetables for 6 weeks can impact the gut microflora and markers of inflammation
of overweight and obese women.
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.
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.
Inclusion Criteria:
- BMI: 25-40 kg/m2
- Non-smoker
- No previous diagnosis of cancer
- No thyroid disease
- No diabetes
- Willing to consume 1 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 < 25 kg/m2
- Smoker
- Taking medications that affect appetite or body weight
- Uncontrolled Hypertension
- Diabetes
- Not willing to consume 1 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
We found this trial at
1
site
1 UNF Drive
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Principal Investigator: Andrea Y Arikawa, PhD
Phone: 904-620-1433
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