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Sponsored by: |
Abbott Nutrition |
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Information provided by: | Abbott Nutrition |
ClinicalTrials.gov Identifier: | NCT00798291 |
To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.
Condition | Intervention | Phase |
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Aged |
Other: Ad lib diet and Control placebo Other: Ad lib diet and An 777 Other: Ad lib diet/ placebo/ exercise Other: Ad lib diet; AN 777; exercise |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study |
Official Title: | Evaluation of AN777 in Elderly Subjects |
Estimated Enrollment: | 108 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ad lib diet/placebo: Placebo Comparator
Ad lib diet and control product placebo
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Other: Ad lib diet and Control placebo
one packet with water two times a day
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Ad lib diet/AN 777: Experimental
Ad lib diet and AN 777
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Other: Ad lib diet and An 777
one packet with water two times a day
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Ad lib diet/placebo/exercise: Active Comparator
Diet ad lib; exercise; and placebo
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Other: Ad lib diet/ placebo/ exercise
one packet with water two times a day; resistance training three times a week
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Ad lib diet/ AN 777/ exercise: Experimental
Diet ad lib; AN 777; exercise
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Other: Ad lib diet; AN 777; exercise
one packet with water two times a day; resistance training three times a week
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bobbie Swearengin, RN | 614 624 7172 | Bobbie.Swearengin@abbott.com |
United States, Oklahoma | |
Department of Health and Exercise Science, University of Oklahoma | Recruiting |
Norman, Oklahoma, United States, 73019 | |
Principal Investigator: Jeffrey R Stout, PhD, FNSCA, FACSM, FISSN |
Study Chair: | Catherine Johnson, PhD | Abbott Nutrition |
Responsible Party: | Abbott Nutrition ( Bobbie Swearengin ) |
Study ID Numbers: | BK32 |
Study First Received: | November 25, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00798291 History of Changes |
Health Authority: | United States: Institutional Review Board |