Study of Protein Metabolism in Healthy Older Subjects

Study of Acute Muscle Protein Metabolism in Healthy Older Subjects

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

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Other: Control protein powder sachet; Other: Experimental protein powder sachet

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3DT
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Control protein powder sachet	Other: Control protein powder sachet; mixed with 8 oz. water
Experimental: Experimental; Experimental protein powder sachet	Other: Experimental protein powder sachet; mixed with 8 oz. water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein Metabolism	Study Visit 1 and Study Visit 2	Change from - 1 to + 5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macrovascular Blood Flow	Study Visit 1 and Study Visit 2	Change from -1 to +5 hours
Glycemic Markers	Study Visit 1 and Study Visit 2	Change from -1 to +5 hours
Microvascular Blood Flow	Study Visit 1 and Study Visit 2	Change from -1 to +5 hours

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Min Tian, PhD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BL19