Comparison of Psyllium and Microcrystalline Cellulose on Glycemic Measures in Subjects With Impaired Fasting Glucose

This study will be conducted at a single study center. Approximately 40 subjects with
pre-type 2 diabetes will be enrolled and randomized in this study.

This 22-week study consists of 3 periods: an 8-week treatment period (Visits 2-4), a 6-week
washout period, and an 8-week treatment period (Visits 5-7).

Inclusion Criteria:

- be male or female,

- at least 18 years of age

- in generally good health for the pre-type 2 diabetes population;

- if female, be postmenopausal or if of child-bearing capacity agree to use an adequate
form of contraception

- have not used any psyllium containing products within the past 3 months;

- be willing to refrain from taking any psyllium containing products during the study;

- be willing to maintain a lifestyle habits for the duration of the study;

- have a fasting serum glucose of 110 - 125 mg/dL

Exclusion Criteria:

- if female, are pregnant or nursing (lactating);

- have a history of diabetes (diagnosis) or is currently taking medications for
diabetes

- participated in a clinical drug study or used investigational drug during the
previous 30 days;

- have symptoms and signs suggestive of significant underlying disease, or acute onset
of new symptoms and signs of major organ disease, that could become unstable during
the trial requiring urgent medical intervention

- have evidence of or treatment history of malignancy within the previous 5 years;

- currently alcohol dependent;

- used anti-psychotics in the previous 3 months;

- used systemic steroidal agents within the last 30 days;

- had used oral or systemic antibiotics or any over-the-counter (OTC) bactericidal
medication (eg, bismuth salts) within the last 30 days;

- has been taking any medication that may affect blood glucose or GI motility (eg,
calcium channel blockers, beta blockers, antimuscarinics, salicylates etc.) for less
than 30 days or 5 times the half life of the drug (need to be stable on the
medication);

- have evidence of immunodeficiency including subjects currently taking systemic
corticosteroids or immunosuppressive drugs

- have a major psychiatric disorder, including major depression, psychoses, alcohol or
substance abuse within the past 2 years;

- has a known sensitivity or allergy to any components of study products, including
psyllium and aspartame (see Section 3.5.3);

- were previously screened (ie, Visit 1 procedures) for participation in this study and
failed to meet entry criteria;

- have difficulty swallowing