Status:
COMPLETED
Fermented and Fiber-rich Food (FeFiFo) Study
Lead Sponsor:
Stanford University
Conditions:
Metabolic Syndrome
Microbiome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective is to contrast the degree to which increased consumption of dietary fiber vs. fermented food can decrease inflammation, increase microbiota diversity and can impact microbiota pr...
Detailed Description
The gut microbiota is central to human health, and the modern, industrialized gut microbiota has been linked to numerous chronic diseases that are driven by inflammation. It is likely dietary changes ...
Eligibility Criteria
Inclusion
- 18 and older, both genders, all ethnic backgrounds
- Healthy subjects willing and able to provide blood, as well as stool specimens
- Able to provide signed and dated informed consent.
Exclusion
- Body Mass Index higher than 40.
- Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure greater than 160/100, oral temperature greater than 100 degrees F, pulse greater than 100.
- Use of any of the following drugs within the last 6 months:
- systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
- oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
- cytokines;
- methotrexate or immunosuppressive cytotoxic agents;
- large doses of commercial probiotics consumed (greater than or equal to 10e8 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component.
- consumption of \> 20 g fiber/day and \> 7 servings of fermented foods per week.
- Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
- Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
- Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.
- Positive test for HIV, HBV or HCV.
- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency ( primary or acquired) including HIV infection.
- Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- History of active uncontrolled gastrointestinal disorders or diseases including:
- inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
- irritable bowel syndrome (IBS) (moderate-severe);
- persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
- chronic constipation.
- Female who is pregnant or lactating.
Key Trial Info
Start Date :
August 29 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2017
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03275662
Start Date
August 29 2016
End Date
June 2 2017
Last Update
February 24 2023
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305