Trial record 6 of 7 for:    an777

Evaluation of an Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Abbott Nutrition
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT02090387
First received: March 17, 2014
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the lean body mass (LBM) loss that occurs after bed rest.


Condition Intervention
Healthy
Other: ONS without AN777
Other: ONS containing AN777

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Evaluation of a Complete Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects During Bed Rest and Recovery.

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Total lean body mass [ Time Frame: Baseline to Study Day 10 ] [ Designated as safety issue: No ]
    Change from baseline


Secondary Outcome Measures:
  • Hand-grip strength [ Time Frame: Baseline, Study Day 10, Study Week 6 and 12 ] [ Designated as safety issue: No ]
    Change from baseline

  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, Study Day 10, Study Week 6 and 12 ] [ Designated as safety issue: No ]
    Change from baseline

  • Isokinetic leg strength [ Time Frame: Baseline, Study Day 10 and Study Week 12 ] [ Designated as safety issue: No ]
    Change from baseline

  • Body Mass Index (BMI) [ Time Frame: Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    Calculated BMI = weight/height2 (kg/m2).

  • Lower extremity lean mass [ Time Frame: Baseline, Study Day 10, Study Weeks 6 and 12 ] [ Designated as safety issue: No ]
    Measured by DXA; Change from baseline


Estimated Enrollment: 76
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control ONS
ONS without AN777
Other: ONS without AN777
2 servings a day
Other Name: Commercially available ONS
Experimental: Investigational ONS
ONS containing AN777
Other: ONS containing AN777
2 servings a day
Other Name: Investigational ONS

  Eligibility

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

Inclusion Criteria:

  1. Age ≥ 60 to ≤ 79 years
  2. Body Mass Index (BMI) >20 but ≤ 35 kg/m2.
  3. Short Physical Performance Battery (SPPB) score of > 9 (fully functional with no mobility limitations).
  4. Triacylglyceride (TAG) level is ≤ 250 mg/dl and LDL cholesterol is ≤ 150 mg/dl.
  5. Compliance with the various activity levels required for this study.
  6. Ankle brachial index within the normal range, between 1 and 1.4.
  7. Physical activity score within the 2008 Guidelines for Americans.
  8. Normal-good handgrip strength.

Exclusion Criteria:

  1. Type I or Type II Diabetes Mellitus.
  2. Abnormal fasting blood glucose level.
  3. Major surgery, less than 6 weeks prior to enrollment in the study, or subject has planned elective surgery requiring 2 or more days of hospitalization.
  4. History of pressure ulcers.
  5. Stated history of Deep Vein Thrombosis (DVT), recent pulmonary embolism, carotid atherosclerosis, transient ischemic attack (TIA), or has a positive D-dimer test and lower extremity ultrasound at screening, or a known hypercoaguable condition, or other clotting or bleeding disorders, or is currently prescribed blood thinners.
  6. Varicose veins that would result in significant discomfort while wearing TED hose and/or SCD.
  7. Stated autoimmune disease or active malignant disease.
  8. Estimated glomerular filtration rate is < 60ml/min/1.73m2.
  9. Current significantly impaired liver function or hepatic enzyme tests are ≥2.5 times normal limit.
  10. Significant cardiovascular event ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or subject has evidence of cardiovascular disease assessed during the electrocardiogram (EKG) at screening.
  11. Hypo- or hyper-thyroidism, or other endocrinopathies associated with excessive androgen secretion.
  12. Refractory anemia with hemoglobin value <11.0 g/dl.
  13. Chronic, contagious, infectious disease, such as active tuberculosis, hepatitis B or C, or HIV.
  14. Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or has received corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months.
  15. Currently being prescribed or has taken prescribed (high dose), but not over the counter, anti-inflammatory medication in the 6 weeks prior to screening.
  16. History of allergy to any of the ingredients in the study products.
  17. Currently taking statins and has a stated history of statin induced myopathy.
  18. Obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease.
  19. Stated uncontrolled severe diarrhea, nausea or vomiting.
  20. Amputee.
  21. Actively pursuing weight loss or gain.
  22. Cannot refrain from taking medications/dietary supplements (all forms)/substances that could modulate metabolism or body weight.
  23. Cannot refrain from taking prescription level doses of eicosapentaenoic acid (EPA) ± docosahexaenoic acid (DHA) (≥1g/d), or vitamin D, (>1,000IU/d) during the study.
  24. Cannot refrain from smoking or discontinue the use of nicotine (all forms including patches) or tobacco during the study.
  25. One or more metal implants.
  26. Currently diagnosis or a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance.
  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: NCT02090387

Contacts
Contact: Kristen DeLuca, MS, RD 614-624-5455 kristen.deluca@abbott.com

Locations
United States, Arkansas
University of Arkansas for Medical Sciences (UAMS) Not yet recruiting
Little Rock, Arkansas, United States, 72205-7199
Principal Investigator: Robert Wolfe, PhD         
United States, Florida
Florida Hospital Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Principal Investigator: Bret Goodpaster, PhD         
United States, Texas
Center of Translational Research in Aging & Longevity Recruiting
College Station, Texas, United States, 77843-4253
Principal Investigator: Nicolaas EP Deutz, PhD, MD         
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Owen Kelly, Ph.D Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02090387     History of Changes
Other Study ID Numbers: BL20
Study First Received: March 17, 2014
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014