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OpenTrials
Completed

NCT Number: NCT02052232

Study of 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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Derby, DE22 3DT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental protein powder sachet

Other

mixed with 8 oz. water

Control protein powder sachet

Other

mixed with 8 oz. water

Primary outcomes

  1. Protein Metabolism

    Time frame: Change from - 1 to + 5 hours

    Study Visit 1 and Study Visit 2

Secondary outcomes

  1. Macrovascular Blood Flow

    Time frame: Change from -1 to +5 hours

    Study Visit 1 and Study Visit 2

  2. Glycemic Markers

    Time frame: Change from -1 to +5 hours

    Study Visit 1 and Study Visit 2

  3. Microvascular Blood Flow

    Time frame: Change from -1 to +5 hours

    Study Visit 1 and Study Visit 2

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Study of Acute Muscle Protein Metabolism in Healthy Older Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2014
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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