Clinical trial NCT00945581: Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery
Official title: Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Aged
Keywords: Healthy Elderly volunteers
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives are to evaluate the effect of AN777 on muscle strength loss that occurs during bed rest, and to investigate whether AN777, in association with resistance training, will support muscle strength recovery following bed rest in healthy elderly subjects.


Eligibility criteria: Inclusion Criteria:

* Subject (male or female) is \> 60 to \< 79 years of age.
* Subject has Body Mass Index (BMI)\> 20 \< 35.
* Subject is ambulatory with an SPPB score of \> 9.
* Subject agrees to comply with prescribed activity level.

Exclusion Criteria:

* Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study.
* Subject has stated active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
* Subject has stated history of diabetes or fasting glucose value \> 126 mg/dL.
* Subject has stated presence of partial or full artificial limb.
* Subject has stated kidney disease or serum creatinine \> 1.4 mg/dL.
* Subject has evidence of cardiovascular disease assessed during resting or exercise EKG.
* Subject has untreated hypothyroidism with TSH levels greater than 5.5 microUnits/ml.
* Subject has serum glutamate pyruvate transaminase (SGPT) levels greater than two times upper limit of laboratory-designated normal value.
* Subject has a history of allergy to any of the ingredients in the study products.
* 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 such as gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
* Subject has stated uncontrolled severe diarrhea, nausea or vomiting.

Subject is actively pursuing weight loss.

* Subject is currently taking medications/dietary supplements/substances that could modulate metabolism or weight in the opinion of the principal investigator or physician, e.g. progestational agents, steroids, growth hormone, dronabinol, marijuana, beta-hydroxyl-beta-methylbutyrate (HMB), free amino acid supplements, dietary supplements to aid weight loss. Exceptions for multi-vitamin/mineral supplement, inhaled steroids for asthma, topical or optical steroids and short-term use (less than two weeks) of Dexamethasone.
* Subject cannot refrain from smoking/discontinue the use of nicotine or tobacco.
* Subject has a stated history of Deep Vein Thrombosis (DVT) or a known hypercoaguable condition.
* Subject cannot discontinue current anticoagulant therapy.
* Subject has refractory anemia with hemoglobin value \< 11.5 g/dL.

Primary outcomes:
measure: Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.
timeFrame: 10 weeks
Secondary outcomes:
measure: Lower extremity lean body mass
timeFrame: 10 weeks
measure: Muscle functionality
timeFrame: 10 weeks
measure: Total lean mass
timeFrame: 10 weeks
measure: physical activity levels
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: Abbott Nutrition
name: Suzette Pereira, PhD
role: STUDY_CHAIR
References:
citation: Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.