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Comparison of Medical Nutritional Supplements

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01483976
Enrollment
27
Registered
2011-12-02
Start date
2011-10-31
Completion date
2012-05-31
Last updated
2013-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly

Brief summary

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

Interventions

OTHEROral medical nutritional supplement

orally over a three hour period

OTHERExperimental oral medical nutritional supplement with AN777

orally over a three hour period

Sponsors

Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
60 Years to 90 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in protein metabolismBetween baseline and 8 hours laterVia amino acid tracers

Secondary

MeasureTime frameDescription
Intracellular signaling pathway metabolismBetween Baseline and 8 hours laterVia Amino acid tracers and protein phosphorylation measurements

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026