Study of Protein Metabolism in Healthy Older Subjects

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Other: Control protein powder sachet; Other: Experimental protein powder sachet

• Registration Number: NCT02052232
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Study Start: 2014-03
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Control protein powder sachet	Control protein powder sachet
Experimental	Experimental protein powder sachet	Experimental protein powder sachet

Primary Outcome Measures

Name	Time	Method
Protein Metabolism	Change from - 1 to + 5 hours	Study Visit 1 and Study Visit 2

Secondary Outcome Measures

Name	Time	Method
Microvascular Blood Flow	Change from -1 to +5 hours	Study Visit 1 and Study Visit 2
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

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Derby, United Kingdom