Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly

Sixty healthy, elderly volunteers between the ages of 55 and 85 will be enrolled at one of four clinical sites in the Tampa/St. Petersburg area. Subjects with a history of GI inflammatory conditions (e.g., IBS or diverticulitis) or other clinically significant abnormalities will be excluded from enrollment. Subjects will be randomized to one of two dosing regimens (with or without a 7-day titration period) and to one of three formulations of Ketasyn containing the identical amount of active ingredient, but different amounts of proteins and carbohydrates. Subjects assigned to Group 1 will receive 10 grams active ingredient daily on Days 1-7, followed by a daily dose of 20 grams active ingredient on Days 8-14. Subjects assigned to Group 2 will receive 20 grams active ingredient on Days 1-14. All subjects will have clinic visits on Day 1 and 14; subjects assigned to Group 1 will also have a clinic visit on Day 8. Subjects will fast prior to each clinic visit and have vital signs and routine lab tests performed prior to dosing. A standard breakfast will be served along with the study product, following which blood samples will be collected for product concentration levels.

Inclusion criteria

• No clinically significant abnormal findings on physical exam, vital signs, medical history, ECG, or laboratory results

Exclusion criteria

• Type 1 or uncontrolled Type 2 diabetes
• History of or current inflammation of GI system, e.g. IBS, diverticular disease, gastric or duodenal ulcers, severe GERD requiring daily medication
• History (within past 60 days) of infections
• Clinically significant renal, hepatic, or hematologic abnormalities