Fermented and Fiber-rich Food (FeFiFo) Study

This is an interventional prevention trial for Metabolic Syndrome Read More

Inclusion Criteria:

• 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 Criteria:

• 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:

  1. systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
  2. oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
  3. cytokines;
  4. methotrexate or immunosuppressive cytotoxic agents;
  5. 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.
  6. 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:

  1. inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
  2. irritable bowel syndrome (IBS) (moderate-severe);
  3. persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
  4. chronic constipation.

Female who is pregnant or lactating.