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

NCT ID: NCT00660088

Last Updated: 2008-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-08-31

Brief Summary

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AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative conditions including Alzheimer's disease. The current study is a randomized, open-label trial to compare the safety, tolerability, and PK profiles of 3 formulations of Ketasyn administered on a daily basis for 14 days, with and without a 7-day titration period, in normal, healthy elderly volunteers.

Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

10 gram x 7 days, then 20 gram x 7 days active ingredient of original formulation

Ketasyn

Intervention Type OTHER

10g for 7 days, 20g for 7 or 14 days

2

20 grams x 14 days active ingredient of original formulation

Ketasyn

Intervention Type OTHER

10g for 7 days, 20g for 7 or 14 days

3

10 grams x 7 days; then 20 grams x 7 days of low protein formulation

Ketasyn

Intervention Type OTHER

10g for 7 days, 20g for 7 or 14 days

4

20 grams x 14 days of low protein formulation

Ketasyn

Intervention Type OTHER

10g for 7 days, 20g for 7 or 14 days

5

10 grams x 7 days; then 20 grams x 7 days of high protein formulation

Ketasyn

Intervention Type OTHER

10g for 7 days, 20g for 7 or 14 days

6

20 grams x 14 days of high protein formulation

Ketasyn

Intervention Type OTHER

10g for 7 days, 20g for 7 or 14 days

Interventions

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Ketasyn

10g for 7 days, 20g for 7 or 14 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cerecin

INDUSTRY

Sponsor Role lead

Responsible Party

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Accera, Inc.

Principal Investigators

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Lauren Costantini, PhD

Role: STUDY_DIRECTOR

Cerecin

Locations

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Meridien Research Center

St. Petersburg, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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KET-08-004

Identifier Type: -

Identifier Source: org_study_id