Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Aged	Other: Experimental Nutritional Powder Formula Other: Placebo comparator	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:

Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lower extremity lean body mass [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Muscle functionality [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Total lean mass [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
physical activity levels [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	November 2009
Study Completion Date:	March 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AN777 Powder twice a day	Other: Experimental Nutritional Powder Formula Powder twice a day
Placebo Comparator: Placebo powder Powder twice a day	Other: Placebo comparator Powder twice a day

Eligibility

Ages Eligible for Study:	60 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945581

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

Abbott Nutrition

Investigators

Study Chair:

Suzette Pereira, PhD

Abbott Nutrition

More Information

No publications provided

Responsible Party:	Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier:	NCT00945581 History of Changes
Other Study ID Numbers:	BK37
Study First Received:	July 23, 2009
Last Updated:	March 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Abbott Nutrition:

Healthy Elderly volunteers

ClinicalTrials.gov processed this record on May 19, 2013