Evaluation of AN777 in Elderly Subjects - Full Text View

Sponsored by:	Abbott Nutrition
Information provided by:	Abbott Nutrition
ClinicalTrials.gov Identifier:	NCT00798291

Purpose

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

Condition	Intervention	Phase
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

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:

The primary objective is to evaluate the effect of AN777 on muscle mass change in an elderly population while on an adequate protein intake. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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
Ad lib diet/placebo: Placebo Comparator Ad lib diet and control product placebo	Other: Ad lib diet and Control placebo one packet with water two times a day
Ad lib diet/AN 777: Experimental Ad lib diet and AN 777	Other: Ad lib diet and An 777 one packet with water two times a day
Ad lib diet/placebo/exercise: Active Comparator Diet ad lib; exercise; and placebo	Other: Ad lib diet/ placebo/ exercise one packet with water two times a day; resistance training three times a week
Ad lib diet/ AN 777/ exercise: Experimental Diet ad lib; AN 777; exercise	Other: Ad lib diet; AN 777; exercise one packet with water two times a day; resistance training three times a week

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798291

Contacts

Contact: Bobbie Swearengin, RN

614 624 7172

Bobbie.Swearengin@abbott.com

Locations

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

Sponsors and Collaborators

Abbott Nutrition

Investigators

Study Chair:

Catherine Johnson, PhD

Abbott Nutrition

More Information

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
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009