The RAMP Study - Rejuvenation of the Aging Microbiota With Prebiotics

The objective of this study is to define the impact of a prebiotic supplement on microbiome,
immune system, and metabolic status in older adults. This study will determine the degree to
which a prebiotic supplement can 1) regulate immune status and function including reducing
chronic, systemic inflammation as assessed by high dimensional immune profiling, 2) alter
microbiota composition and function, 3) impact the microbiota metabolites—potential
normalizers of metabolic and immune dysfunction, and 4) alter metabolic markers.

Inclusion Criteria:

- 60 years old and older

- Otherwise, healthy subjects willing and able to provide blood as 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 >= 40

- LDL-C > 190 mg/dL

- Systolic Blood Pressure >160 mmHg OR Diastolic Blood Pressure > 90 mmHg

- Use of any of the following drugs/supplements within the last 2 months:

- systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous,
intramuscular, or oral);

- corticosteroids (intravenous, intramuscular, oral, nasal or inhaled)

- cytokines

- methotrexate or immunosuppressive cytotoxic agents

- metformin

- proton pump inhibitors (PPIs)

- Regular use of any of the following medications:

- regular dose aspirin (>81mg/day)

- opiate pain medication

- Use of large doses of commercial probiotics consumed (greater than or equal to 10-8
cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or
powders in which probiotic is a primary component. Ordinary dietary components such as
fermented beverages/milks, yogurts, foods do not apply.

- Acute disease at the time of enrollment. Acute disease is defined as the presence of a
moderate or severe illness with or without fever. Examples include flu or
gastroenteritis. Defer sampling until subject recover.

- Chronic, clinically significant, unstable (unresolved, requiring on-going changes to
medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic
or renal functional abnormality, as determined by medical history. Type 2 diabetes,
type 1 diabetes, and dialysis will be excluded.

- 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).

- History of active cancer in the past 3 years 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 excessive 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; or > 14 drinks/week.

- Positive test for HIV, HBV or HCV.

- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency
(primary or acquired) including HIV infection.

- Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in
the past five years. Any major bowel resection at any time.

- Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other
nicotine-containing products.

- Any confirmed or suspected autoimmune disease. Examples include multiple sclerosis and
Graves disease.

- Veganism.

- Dairy allergies.