Aged
Conditions
Brief summary
To evaluate whether AN777 with or without exercise affects muscle mass change in elderly subjects.
Interventions
OTHERAd lib diet and Control placebo
one packet with water two times a day
OTHERAd lib diet and An 777
one packet with water two times a day
OTHERAd lib diet/ placebo/ exercise
one packet with water two times a day; resistance training three times a week
OTHERAd lib diet; AN 777; exercise
one packet with water two times a day; resistance training three times a week
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to measure the effects of AN777 on body composition, functional outcomes, strength, and quality of life. | 24 weeks |
Countries
United States
Outcome results
None listed