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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: ONS without AN777; Other: ONS containing AN777

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control ONS; ONS without AN777	Other: ONS without AN777; 2 servings a day; Other Names: Commercially available ONS
Experimental: Investigational ONS; ONS containing AN777	Other: ONS containing AN777; 2 servings a day; Other Names: Investigational ONS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total lean body mass	Change from baseline	Baseline to Study Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand-grip strength	Change from baseline	Baseline, Study Day 10, Study Week 6 and 12
Short Physical Performance Battery (SPPB)	Change from baseline	Baseline, Study Day 10, Study Week 6 and 12
Isokinetic leg strength	Change from baseline	Baseline, Study Day 10 and Study Week 12
Body Mass Index (BMI)	Calculated BMI = weight/height2 (kg/m2).	Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12
Lower extremity lean mass	Measured by DXA; Change from baseline	Baseline, Study Day 10, Study Weeks 6 and 12

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Owen Kelly, Ph.D, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BL20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED