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OpenTrials
Completed

NCT Number: NCT01483976

Comparison of Medical Nutritional Supplements

The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.

Completed

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Key information

Conditions

Age range

60 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and is ≥ 60 and ≤ 90 years of age.
  • Body Mass Index (BMI) > 20.0, but < 35.0.
  • Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
  • Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
  • Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
  • Refrain from intense physical activity between visits.

Exclusion criteria

  • Systemic corticosteroids within the 3 months prior to enrollment.
  • Blood thinner or anticoagulant medication within 1 week prior to enrollment.
  • Glomerular filtration rate (eGFR) of < 40 mL/min/1.73m2.
  • Antibiotics within 1 week prior to enrollment.
  • Major surgery less than 3 months prior to enrollment in the study.
  • Active malignant disease or treated within the last 6 months for cancer.
  • Immunodeficiency disorder.
  • Diabetes
  • Myocardial infarction 3 months prior to enrollment.
  • Chronic obstructive pulmonary disease
  • History of allergy to any of the ingredients in the study products.
  • Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
  • Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
  • Pursuing weight loss or weight gain.
  • Medications/dietary supplements/substances that could modulate metabolism or weight.

Treatment and study plan

Oral medical nutritional supplement

Other

orally over a three hour period

Experimental oral medical nutritional supplement with AN777

Other

orally over a three hour period

Primary outcomes

  1. Change in protein metabolism

    Time frame: Between baseline and 8 hours later

    Via amino acid tracers

Secondary outcomes

  1. Intracellular signaling pathway metabolism

    Time frame: Between Baseline and 8 hours later

    Via Amino acid tracers and protein phosphorylation measurements

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2011
Registry last updated
Jan 31, 2013

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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