Evaluation of AN777 in Elderly Subjects

Aged Clinical Trial

Official title:

Evaluation of AN777 in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798291
• Other study ID #: BK32
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 25, 2008
• Last updated: March 19, 2010
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aged

Intervention

Other:
• Ad lib diet and Control placebo
one packet with water two times a day
• Ad lib diet and An 777
one packet with water two times a day
• 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
one packet with water two times a day; resistance training three times a week

Locations

Country	Name	City	State
United States	Department of Health and Exercise Science, University of Oklahoma	Norman	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to evaluate the effect of AN777 on muscle mass change in an elderly population while on an adequate protein intake.		24 weeks	No
Secondary	The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life.		24 weeks	No