Study of Protein Metabolism in Healthy Older Subjects

NCT02052232 | Completed

• 1 other identifier: BL19
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Protein Metabolism

  Study Visit 1 and Study Visit 2

  Change from - 1 to + 5 hours

Secondary Outcomes (3)

• Macrovascular Blood Flow

  Change from -1 to +5 hours

• Glycemic Markers

  Change from -1 to +5 hours

• Microvascular Blood Flow

  Change from -1 to +5 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

Control protein powder sachet

Other: Control protein powder sachet

Experimental

EXPERIMENTAL

Experimental protein powder sachet

Other: Experimental protein powder sachet

Interventions

Experimental protein powder sachet OTHER

mixed with 8 oz. water

Experimental

Control protein powder sachet OTHER

mixed with 8 oz. water

Control

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

University of Nottingham

Derby, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Min Tian, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: February 3, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

GB (1)