ClinicalTrials.gg
CompletedNCT02090387Updated Jul 11, 2016

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

An interventional study of ONS without AN777 and ONS containing AN777 in Healthy, sponsored by Abbott Nutrition. Completed at 3 sites in United States. Open to participants aged 60 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Abbott Nutrition (part of Abbott) · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
60 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    Control ONS

    ONS without AN777

    Other: ONS without AN777

  • Experimental
    Investigational ONS

    ONS containing AN777

    Other: ONS containing AN777

Interventions

  • OtherONS without AN777

    2 servings a day

    Also known as: Commercially available ONS

  • OtherONS containing AN777

    2 servings a day

    Also known as: Investigational ONS

06

What researchers measure

Primary outcomes

  1. Total lean body mass

    Change from baseline

    Time frame: Baseline to Study Day 10

Secondary outcomes

  1. Hand-grip strength

    Change from baseline

    Time frame: Baseline, Study Day 10, Study Week 6 and 12

  2. Short Physical Performance Battery (SPPB)

    Change from baseline

    Time frame: Baseline, Study Day 10, Study Week 6 and 12

  3. Isokinetic leg strength

    Change from baseline

    Time frame: Baseline, Study Day 10 and Study Week 12

  4. Body Mass Index (BMI)

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

    Time frame: Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12

  5. Lower extremity lean mass

    Measured by DXA; Change from baseline

    Time frame: Baseline, Study Day 10, Study Weeks 6 and 12

07

Study locations

3 sites
  • University of Arkansas for Medical Sciences (UAMS)
    Little Rock, Arkansas 72205-7199, United States
  • Florida Hospital Translational Research Institute for Metabolism and Diabetes
    Orlando, Florida 32804, United States
  • Center of Translational Research in Aging & Longevity
    College Station, Texas 77843-4253, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02090387
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Mar 18, 2014
Start date
Mar 2014
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Jul 11, 2016

Study contacts

Owen Kelly, Ph.D
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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