Evaluation of AN777 in Elderly Subjects

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Aged

Treatments: Other: Ad lib diet and An 777; Other: Ad lib diet and Control placebo; Other: Ad lib diet/ placebo/ exercise; Other: Ad lib diet; AN 777; exercise

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798291

BK32

Details and patient eligibility

About

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

Enrollment: 108 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

108 participants in 4 patient groups, including a placebo group

Ad lib diet/placebo

Placebo Comparator group

Description:

Ad lib diet and control product placebo

Treatment:

Other: Ad lib diet and Control placebo

Ad lib diet/AN 777

Experimental group

Description:

Ad lib diet and AN 777

Treatment:

Other: Ad lib diet and An 777

Ad lib diet/placebo/exercise

Active Comparator group

Description:

Diet ad lib; exercise; and placebo

Treatment:

Other: Ad lib diet/ placebo/ exercise

Ad lib diet/ AN 777/ exercise

Experimental group

Description:

Diet ad lib; AN 777; exercise

Treatment:

Other: Ad lib diet; AN 777; exercise