Study of Protein Metabolism in Healthy Older Subjects

Malnutrition Clinical Trial

Official title:

Study of Acute Muscle Protein Metabolism in Healthy Older Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052232
• Other study ID #: BL19
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: June 16, 2016
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2016
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• Experimental protein powder sachet
mixed with 8 oz. water
• Control protein powder sachet
mixed with 8 oz. water

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Derby

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein Metabolism	Study Visit 1 and Study Visit 2	Change from - 1 to + 5 hours	No
Secondary	Macrovascular Blood Flow	Study Visit 1 and Study Visit 2	Change from -1 to +5 hours	No
Secondary	Glycemic Markers	Study Visit 1 and Study Visit 2	Change from -1 to +5 hours	No
Secondary	Microvascular Blood Flow	Study Visit 1 and Study Visit 2	Change from -1 to +5 hours	No