Text Size

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
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of AN777 in Elderly Subjects

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ad lib diet/placebo
Ad lib diet and control product placebo
 Other: Ad lib diet and Control placebo
one packet with water two times a day
Experimental: Ad lib diet/AN 777
Ad lib diet and AN 777
 Other: Ad lib diet and An 777
one packet with water two times a day
Active Comparator: Ad lib diet/placebo/exercise
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
Experimental: Ad lib diet/ AN 777/ exercise
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:

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

Locations
United States, Oklahoma
Department of Health and Exercise Science, University of Oklahoma
Norman, Oklahoma, United States, 73019
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Catherine Johnson, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00798291     History of Changes
Other Study ID Numbers: BK32
Study First Received: November 25, 2008
Last Updated: March 19, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013