Evaluation of AN777 in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00798291
First received: November 25, 2008
Last updated: March 19, 2010
Last verified: March 2010

November 25, 2008
March 19, 2010
October 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00798291 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of AN777 in Elderly Subjects
Evaluation of AN777 in Elderly Subjects

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Aged
  • Other: Ad lib diet and Control placebo
    one packet with water two times a day
  • Other: Ad lib diet and An 777
    one packet with water two times a day
  • Other: Ad lib diet/ placebo/ exercise
    one packet with water two times a day; resistance training three times a week
  • Other: Ad lib diet; AN 777; exercise
    one packet with water two times a day; resistance training three times a week
  • Placebo Comparator: Ad lib diet/placebo
    Ad lib diet and control product placebo
    Intervention: Other: Ad lib diet and Control placebo
  • Experimental: Ad lib diet/AN 777
    Ad lib diet and AN 777
    Intervention: Other: Ad lib diet and An 777
  • Active Comparator: Ad lib diet/placebo/exercise
    Diet ad lib; exercise; and placebo
    Intervention: Other: Ad lib diet/ placebo/ exercise
  • Experimental: Ad lib diet/ AN 777/ exercise
    Diet ad lib; AN 777; exercise
    Intervention: Other: Ad lib diet; AN 777; exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject (male or female) is at least 65 years of age
  2. Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over
  3. Subject has Body Mass Index (BMI) > 20.0 but <30.0
  4. Subject is ambulatory
  5. Subject agrees to maintain current activity level

Exclusion Criteria:

  1. Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study
  2. Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix
  3. Subject has stated immunodeficiency disorder
  4. Subject has stated history of diabetes
  5. Subject has stated presence of partial or full artificial limb
  6. Subject has stated kidney disease
  7. Subject has stated history of uncontrollable hypertension
  8. Subject had myocardial infarction within the last 3 months
  9. Subject had recent antibiotic use (within 1 week prior to screening).
  10. Subject has a history of allergy to any of the ingredients in the study products
  11. 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
  12. Subject has stated uncontrolled severe diarrhea, nausea or vomiting
  13. Subject has untreated clinically significant ascites, pleural effusion or edema
  14. 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
  15. Subject is actively pursuing weight loss
  16. 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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00798291
BK32
Yes
Bobbie Swearengin, Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Catherine Johnson, PhD Abbott Nutrition
Abbott Nutrition
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP