Evaluation of AN777 in Elderly Subjects

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Aged

In brief

To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.

Key facts

Study ID: NCT00798291
Run by: Abbott Nutrition
People needed: 108
Starts: 2008-10-01
Expected to finish: 2010-01-01
Last updated by the study team: 2010-03-22

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Department of Health and Exercise Science, University of Oklahoma — Norman, Oklahoma, United States

Full record on ClinicalTrials.gov

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