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Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00945581
First received: July 23, 2009
Last updated: March 28, 2011
Last verified: March 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Abbott Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 November 20, 2014