Evaluation of an Oral Nutritional Supplement Containing AN777

Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01191125

Enrollment

331

Registered

2010-08-30

Start date

2011-02-28

Completion date

2012-09-30

Last updated

2013-03-07

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

Conditions

Malnutrition, Sarcopenia

Brief summary

To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.

Interventions

OTHERmedical food with AN777

Two(220 mL)servings every day for six months

OTHERoral nutritional formula

Two (220 mL) servings daily for six months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

Healthy volunteers

Inclusion criteria

Subject (male or female) is \> or equal to 65 and \< or equal to 90 years of age Subject is ambulatory Subject has a Subjective Global Assessment of B or C Subject has gait speed \<0.8 m/s AND/OR low hand-grip strength Subject has Class 1 or Class 2 sarcopenia Subject agrees to refrain from starting a resistance exercise program

Exclusion criteria

Subject has type 1 or type 2 diabetes Subject has inflammatory disease with elevated high sensitivity C-reactive protein Subject has renal function impairment Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease Subject reports of current active malignant disease or other significant medical diagnoses. Subject reports a history of allergy to any of the ingredients in the study products Subject reports currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight.

Design outcomes

Primary

Measure	Time frame
Knee extensor strength	Six months

Secondary

Measure	Time frame
Leg muscle mass	Six months
Body Weight	Six months
Functional measures	Six months

Countries

Belgium, Italy, Mexico, Poland, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

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