Clinical trial NCT02090387: Evaluation of an Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects.
Official title: Evaluation of a Complete Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects During Bed Rest and Recovery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-03-18
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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, 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.

Primary outcomes:
measure: Total lean body mass
timeFrame: Baseline to Study Day 10
Secondary outcomes:
measure: Hand-grip strength
timeFrame: Baseline, Study Day 10, Study Week 6 and 12
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, Study Day 10, Study Week 6 and 12
measure: Isokinetic leg strength
timeFrame: Baseline, Study Day 10 and Study Week 12
measure: Body Mass Index (BMI)
timeFrame: Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12
measure: Lower extremity lean mass
timeFrame: Baseline, Study Day 10, Study Weeks 6 and 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (UAMS)
state: Arkansas
city: Orlando
country: United States
facility: Florida Hospital Translational Research Institute for Metabolism and Diabetes
state: Florida
city: College Station
country: United States
facility: Center of Translational Research in Aging & Longevity
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Owen Kelly, Ph.D
role: STUDY_CHAIR
References: