An Oral Nutritional Supplement Study in Older Malnourished Spanish Population

Abbott

Status

Unknown

Conditions

Malnutrition

Treatments

Other: Nutritional Supplement

Study type

Observational

Funder types

Industry

Identifiers

NCT02404987

DA07

Details and patient eligibility

About

Post-marketing observational study of a nutritional care plan, including a higher calorie, higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished. The objective is to assess the impact of the ONS on body weight, activities of daily living and quality of life.

Enrollment

224 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study.
Considered malnourished, or is at risk for malnutrition based on NRS 2002 score ≥3.
≥65 years of age.
Conforms to the requirements set forth on the study product label.
Under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/d of the study ONS, orally, by their health care professional.
Free living or residing in a nursing home.
Estimated, or measured, glomerular filtration rate >60ml/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) Study equation) within 60 days of beginning their nutritional care plan.
Body mass index (BMI) is <30 kg/m2.
Study physician determines the subject is fit to participate.