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



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:60 - 79
Updated:4/21/2016
Start Date:March 2014
End Date:August 2017
Contact:Kristen DeLuca, MS, RD
Email:kristen.deluca@abbott.com
Phone:614-624-5455

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Evaluation of a Complete Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects During Bed Rest and Recovery.

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


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.
We found this trial at
3
sites
College Station, Texas 77843
Principal Investigator: Nicolaas EP Deutz, PhD, MD
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from
College Station, TX
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Little Rock, Arkansas 72205
Principal Investigator: Robert Wolfe, PhD
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from
Little Rock, AR
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Orlando, Florida 32804
Principal Investigator: Bret Goodpaster, PhD
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from
Orlando, FL
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