Clinical trial NCT00798291: Evaluation of AN777 in Elderly Subjects
Official title: Evaluation of AN777 in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aged
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
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.
timeFrame: 24 weeks
Secondary outcomes:
measure: The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Norman
country: United States
facility: Department of Health and Exercise Science, University of Oklahoma
state: Oklahoma
Study officials:
affiliation: Abbott Nutrition
name: Catherine Johnson, PhD
role: STUDY_CHAIR
References:
citation: Fukuda DH, Stout JR, Moon JR, Smith-Ryan AE, Kendall KL, Hoffman JR. Effects of resistance training on classic and specific bioelectrical impedance vector analysis in elderly women. Exp Gerontol. 2016 Feb;74:9-12. doi: 10.1016/j.exger.2015.12.002. Epub 2015 Dec 2.
citation: Stout JR, Fukuda DH, Kendall KL, Smith-Ryan AE, Moon JR, Hoffman JR. beta-Hydroxy-beta-methylbutyrate (HMB) supplementation and resistance exercise significantly reduce abdominal adiposity in healthy elderly men. Exp Gerontol. 2015 Apr;64:33-4. doi: 10.1016/j.exger.2015.02.012. Epub 2015 Feb 17.