Comparison of Medical Nutritional Supplements

Abbott

Status and phase: Completed; Phase 3

Conditions: Elderly

Treatments: Other: Experimental oral medical nutritional supplement with AN777; Other: Oral medical nutritional supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01483976

BK96

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Male

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups

Oral medical nutritional supplement without AN777

Active Comparator group

Description:

orally over a three hour period

Treatment:

Other: Oral medical nutritional supplement

Experimental oral medical nutritional supplement with AN777

Experimental group

Description:

orally over a three hour period

Treatment:

Other: Experimental oral medical nutritional supplement with AN777