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Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00945581
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : March 29, 2011
Information provided by:
Abbott Nutrition

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.

Condition or disease Intervention/treatment Phase
Aged Other: Experimental Nutritional Powder Formula Other: Placebo comparator Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery
Study Start Date : November 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Lower extremity muscle strength changes after 10 days of bed rest, followed by changes after an 8-week recovery period. [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Lower extremity lean body mass [ Time Frame: 10 weeks ]
  2. Muscle functionality [ Time Frame: 10 weeks ]
  3. Total lean mass [ Time Frame: 10 weeks ]
  4. physical activity levels [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00945581

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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Abbott Nutrition
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Study Chair: Suzette Pereira, PhD Abbott Nutrition
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director Clinical Research Operations, Abbott Nutrition Identifier: NCT00945581    
Other Study ID Numbers: BK37
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: March 2011
Keywords provided by Abbott Nutrition:
Healthy Elderly volunteers