CClinicalTrials.gg
CompletedNCT01483976Updated Jan 31, 2013

Comparison of Medical Nutritional Supplements

A Phase 3 interventional study of Oral medical nutritional supplement and Experimental oral medical nutritional supplement with AN777 in Elderly, sponsored by Abbott Nutrition. Completed at 1 site in United States. Open to male participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-31.

Sponsored by Abbott Nutrition · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Elderly
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Active comparator
    Oral medical nutritional supplement without AN777

    orally over a three hour period

    Other: Oral medical nutritional supplement

  • Experimental
    Experimental oral medical nutritional supplement with AN777

    orally over a three hour period

    Other: Experimental oral medical nutritional supplement with AN777

Interventions

  • OtherOral medical nutritional supplement

    orally over a three hour period

  • OtherExperimental oral medical nutritional supplement with AN777

    orally over a three hour period

06

What researchers measure

Primary outcomes

  1. Change in protein metabolism

    Via amino acid tracers

    Time frame: Between baseline and 8 hours later

Secondary outcomes

  1. Intracellular signaling pathway metabolism

    Via Amino acid tracers and protein phosphorylation measurements

    Time frame: Between Baseline and 8 hours later

07

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01483976
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Dec 2, 2011
Start date
Oct 2011
Primary completion
Mar 2012
Completion
May 2012
Last update
Jan 31, 2013

Study contacts

Vikkie Mustad, PhD
study chair · Abbott Nutrition

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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