Status:
COMPLETED
Evaluation of AN777 in Elderly Subjects
Lead Sponsor:
Abbott Nutrition
Conditions:
Aged
Eligibility:
All Genders
65+ years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.
Eligibility Criteria
Inclusion
- Subject (male or female) is at least 65 years of age
- Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over
- Subject has Body Mass Index (BMI) \> 20.0 but \<30.0
- Subject is ambulatory
- Subject agrees to maintain current activity level
Exclusion
- Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study
- Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
- Subject has stated immunodeficiency disorder
- Subject has stated history of diabetes
- Subject has stated presence of partial or full artificial limb
- Subject has stated kidney disease
- Subject has stated history of uncontrollable hypertension
- Subject had myocardial infarction within the last 3 months
- Subject had recent antibiotic use (within 1 week prior to screening).
- Subject has a history of allergy to any of the ingredients in the study products
- Subject has an obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other major gastrointestinal disease
- Subject has stated uncontrolled severe diarrhea, nausea or vomiting
- Subject has untreated clinically significant ascites, pleural effusion or edema
- Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder or any other psychological condition that may interfere with study product consumption
- Subject is actively pursuing weight loss
- Subject is currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids and short-term use (less than two weeks) of dexamethasone
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00798291
Start Date
October 1 2008
End Date
January 1 2010
Last Update
March 22 2010
Active Locations (1)
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1
Department of Health and Exercise Science, University of Oklahoma
Norman, Oklahoma, United States, 73019