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

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ClinicalTrials.gov Identifier: NCT02090387
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : July 11, 2016
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Other: ONS without AN777 Other: ONS containing AN777 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : March 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Total lean body mass [ Time Frame: Baseline to Study Day 10 ]
    Change from baseline

Secondary Outcome Measures :
  1. Hand-grip strength [ Time Frame: Baseline, Study Day 10, Study Week 6 and 12 ]
    Change from baseline

  2. Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, Study Day 10, Study Week 6 and 12 ]
    Change from baseline

  3. Isokinetic leg strength [ Time Frame: Baseline, Study Day 10 and Study Week 12 ]
    Change from baseline

  4. 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 ]
    Calculated BMI = weight/height2 (kg/m2).

  5. Lower extremity lean mass [ Time Frame: Baseline, Study Day 10, Study Weeks 6 and 12 ]
    Measured by DXA; Change from baseline

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:

  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.

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 ClinicalTrials.gov identifier (NCT number): NCT02090387

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United States, Arkansas
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205-7199
United States, Florida
Florida Hospital Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
United States, Texas
Center of Translational Research in Aging & Longevity
College Station, Texas, United States, 77843-4253
Sponsors and Collaborators
Abbott Nutrition
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Study Chair: Owen Kelly, Ph.D Abbott Nutrition
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT02090387    
Obsolete Identifiers: NCT02238600
Other Study ID Numbers: BL20
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided