Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome

The centrality of the gut microbiota to human health has emerged in just the last decade,
with the last three years implicating our modern, deteriorated gut microbiota in numerous
chronic diseases. It is likely dietary changes in the last half-century consistent with
adoption of the Western diet have had an adverse impact on the gut microbiota. A critically
important next step in this field of research is to identify how different probiotic
supplements can potentially restore the microbiota in alignment with the optimization of
human health, particularly in regard to the reversal or prevention of chronic diseases
including obesity, metabolic syndrome, and inflammatory bowel disease. This study is designed
to elicit and contrast the amount of increase in microbiota diversity and related metabolic
output achievable following consumption of a probiotic supplement commonly available to the
general population. The results could contribute to dietary recommendations for reversing the
chronic disease epidemics of westernization.

Inclusion Criteria:

- 18 and older

- Must have "metabolic syndrome" as defined by having at least 3 of the 5 following
criteria: (per ATP-III Guideline):

1. Waist circumference >102 cm for men, and >88 cm for women

2. Blood pressure >130 mmHg or >85 mmHg, or on antihypertensive drug treatment in a
patient with a history of hypertension

Blood values (measured by fingerstick, fasting sample):

3. Triglycerides >150 mg/dL, or on drug treatment for elevated triglycerides

4. HDL-cholesterol <40 mg/dL for men, <50 mg/dL for women, or on drug treatment for
low HDL

5. Glucose >100 mgdL, or on drug treatment for elevated glucose

- Otherwise, healthy subjects willing and able to provide blood and well as stool
specimens

- Must be able to provide signed and dated informed consent and be willing to follow
protocol

Exclusion Criteria:

- Body Mass Index (BMI) ≥ 40

- LDL >160 mg/dL.

- Vital signs outside of acceptable range at Screening Visit: blood pressure >159/99,
oral temperature ≥ 100°F, pulse >100.

- Use of any of the following drugs within the last 6 months:systemic antibiotics (must
be discontinued and avoided for 2 months prior to the study start), antifungals,
antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous,
intramuscular, nasal or inhaled corticosteroids; cytokines; methotrexate or
immunosuppressive cytotoxic agents;

- Use of large doses of commercial probiotics consumed within the last 6 months (greater
than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges,
chewing gum or powders in which probiotic is a primary component (must be discontinued
and avoided for one month prior to the study start). Ordinary dietary components such
as fermented beverages/milks, yogurts, foods do not apply.