Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

Aged Clinical Trial

Official title:

Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945581
• Other study ID #: BK37
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 23, 2009
• Last updated: March 28, 2011
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aged

Intervention

Other:
• Experimental Nutritional Powder Formula
Powder twice a day
• Placebo comparator
Powder twice a day

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period.		10 weeks	No
Secondary	Lower extremity lean body mass		10 weeks	No
Secondary	Muscle functionality		10 weeks	No
Secondary	Total lean mass		10 weeks	No
Secondary	physical activity levels		10 weeks	No