Clinical trial NCT02052232: Study of Protein Metabolism in Healthy Older Subjects
Official title: Study of Acute Muscle Protein Metabolism in Healthy Older Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 39
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.


Eligibility criteria: 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

Primary outcomes:
measure: Protein Metabolism
timeFrame: Change from - 1 to + 5 hours
Secondary outcomes:
measure: Macrovascular Blood Flow
timeFrame: Change from -1 to +5 hours
measure: Glycemic Markers
timeFrame: Change from -1 to +5 hours
measure: Microvascular Blood Flow
timeFrame: Change from -1 to +5 hours
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: Abbott Nutrition
name: Min Tian, PhD
role: STUDY_CHAIR
References: