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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: ONS without AN777; Other: ONS containing AN777

• Registration Number: NCT02090387
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-07
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control ONS	ONS without AN777	ONS without AN777
Investigational ONS	ONS containing AN777	ONS containing AN777

Primary Outcome Measures

Name	Time	Method
Total lean body mass	Baseline to Study Day 10	Change from baseline

Secondary Outcome Measures

Name	Time	Method
Hand-grip strength	Baseline, Study Day 10, Study Week 6 and 12	Change from baseline
Short Physical Performance Battery (SPPB)	Baseline, Study Day 10, Study Week 6 and 12	Change from baseline
Isokinetic leg strength	Baseline, Study Day 10 and Study Week 12	Change from baseline
Body Mass Index (BMI)	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).
Lower extremity lean mass	Baseline, Study Day 10, Study Weeks 6 and 12	Measured by DXA; Change from baseline

Trial Locations

Locations (3)

Florida Hospital Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States

Center of Translational Research in Aging & Longevity; 🇺🇸 College Station, Texas, United States

University of Arkansas for Medical Sciences (UAMS); 🇺🇸 Little Rock, Arkansas, United States