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

Completed · Not applicable

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02090387

Run by

Abbott Nutrition

People needed

76

Starts

2014-03-01

Expected to finish

2016-04-01

Last updated by the study team

2016-07-11

Who can join

Age: 60 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 60 to ≤ 79 years
• Body Mass Index (BMI) >20 but ≤ 35 kg/m2.
• Short Physical Performance Battery (SPPB) score of > 9 (fully functional with no mobility limitations).
• Triacylglyceride (TAG) level is ≤ 250 mg/dl, LDL cholesterol is ≤ 155 mg/dl, total cholesterol level is ≤ 250 mg/dl.
• Compliance with the various activity levels required for this study.
• Ankle brachial index within the normal range, between 1 and 1.4.
• Physical activity score within the 2008 Guidelines for Americans.
• Normal-good handgrip strength.

You may not qualify if…

• Type I or Type II Diabetes Mellitus.
• Fasting blood glucose level of >115 mg/dl.
• 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.
• History of pressure ulcers.
• 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.
• Varicose veins that would result in significant discomfort while wearing TED hose and/or SCD.
• Stated autoimmune disease or active malignant disease.
• Estimated glomerular filtration rate is < 50ml/min/1.73m2.
• Current significantly impaired liver function or hepatic enzyme tests are ≥2.5 times normal limit.
• Significant cardiovascular event ≤ 6 months prior to screening visit; or stated history of congestive heart failure.
• Untreated hypo- or hyper-thyroidism, or other endocrinopathies associated with excessive androgen secretion.
• Refractory anemia with hemoglobin value <11.0 g/dl.
• Chronic, contagious, infectious disease, such as active tuberculosis, hepatitis B or C, or HIV.
• 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.
• 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.
• History of allergy to any of the ingredients in the study products.
• Deleted
• Obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease.
• Stated uncontrolled severe diarrhea, nausea or vomiting.
• Amputee.
• Actively pursuing weight loss or gain.
• Cannot refrain from taking medications/dietary supplements (all forms)/substances that could modulate metabolism or body weight.
• 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.
• Cannot refrain from smoking or discontinue the use of nicotine (all forms including patches) or tobacco during the study.
• One or more metal implants.

Where it is running

• University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States
• 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

Full record on ClinicalTrials.gov

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