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 October 2015 by Abbott Nutrition
Information provided by (Responsible Party):
Abbott Nutrition Identifier:
First received: March 17, 2014
Last updated: October 26, 2015
Last verified: October 2015
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
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: August 2017
Estimated Primary Completion Date: August 2017 (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


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

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, LDL cholesterol is ≤ 155 mg/dl, total cholesterol level is ≤ 250 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. Fasting blood glucose level of >115 mg/dl.
  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 elevated D-dimer test, a positive ultrasound for DVT, pulmonary embolism, carotid atherosclerosis, transient ischemic attack (TIA), or stated 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 < 50ml/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.
  11. Untreated 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 pain/anti-inflammatory medication and/or is regularly consuming over the counter pain/anti-inflammatory medication for chronic, or persistent, pain, including but not limited to arthritic conditions, fibromyalgia, and continuous localized pain.
  16. History of allergy to any of the ingredients in the study products.
  17. Deleted
  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 long chain n-3 polyunsaturated fatty acids (PUFA) (eicosapentaenoic acid (EPA) ± docosahexaenoic acid (DHA) ± α-linolenic acid (ALA)), or vitamin D, at levels that are significantly higher than the established Acceptable Macronutrient Distribution Range (AMDR), or recommended by the American Heart Association (500 mg/d total EPA+DHA), 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.
  27. Cannot abstain from alcohol use during the study.
  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 identifier: NCT02090387

Contact: Kristen DeLuca, MS, RD 614-624-5455

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
Study Chair: Owen Kelly, Ph.D Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition Identifier: NCT02090387     History of Changes
Obsolete Identifiers: NCT02238600
Other Study ID Numbers: BL20
Study First Received: March 17, 2014
Last Updated: October 26, 2015
Health Authority: United States: Institutional Review Board processed this record on November 27, 2015