Malnutrition
Conditions
Brief summary
This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.
Interventions
OTHERExperimental protein powder sachet
mixed with 8 oz. water
OTHERControl protein powder sachet
mixed with 8 oz. water
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 60 and ≤ 75 years * Body Mass Index (BMI) \> 23.0 to \< 30.0 * Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance * Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study.
Exclusion criteria
* Diagnosis of diabetes * Active pursuit of weight loss * Poorly controlled hypertension or hypotension * Untreated hypothyroidism or hyperthyroidism * Anemia or abnormally functioning kidneys or liver * A significant cardiovascular event within ≤ 6 months; or stated history of congestive heart failure; or evidence of clinically active cardiovascular disease assessed during the screening EKG * Peripheral arterial disease or other diseases that preclude proper limb blood flow * Chronic, contagious, infectious disease * Current infection or corticosteroid treatment within the last 3 months * Clotting or bleeding disorders, stated history of Deep Vein Thrombosis (DVT) and/or a known hypercoagulable condition * In condition deemed unsuitable for study based upon study physician assessment * Surgery requiring \>2 days of hospitalization in the last 3 weeks and/or planned elective surgery requiring \>2 days of hospitalization during the course of the study * Current active malignant disease or was treated within the last 6 months for cancer * An amputee * Obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease * Diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse * Cannot refrain from taking * High doses of fish oil, or omega-3 supplements, or high doses of vitamin D * Medications/dietary supplements/herbals or substances that are considered anabolic, or reduce weight * Any pulmonary anti-inflammatory medication or bronchodilators on the day of and 48 hours prior to study visits 1 and 2 * NSAIDS or acetaminophen on the day of and 48 hours prior to study visits 1 and 2 * Chronic use of nicotine * Allergic or intolerant to any ingredient found in the study products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein Metabolism | Change from - 1 to + 5 hours | Study Visit 1 and Study Visit 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macrovascular Blood Flow | Change from -1 to +5 hours | Study Visit 1 and Study Visit 2 |
| Glycemic Markers | Change from -1 to +5 hours | Study Visit 1 and Study Visit 2 |
| Microvascular Blood Flow | Change from -1 to +5 hours | Study Visit 1 and Study Visit 2 |
Countries
United Kingdom
Outcome results
None listed