An Oral Nutritional Supplement Study in Older Malnourished Spanish Population

• Conditions: Malnutrition
• Interventions: Other: Nutritional Supplement

• Registration Number: NCT02404987
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2015-03
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-27
• Last Update Submitted: 2015-03-27
• Study First Posted: 2015-04-01
• Last Update Posted: 2015-04-01
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nutritional Supplement	Nutritional Supplement	Free living and residing and nursing home malnourished patients

Primary Outcome Measures

Name	Time	Method
Body Weight	Change from baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	Change from baseline to 12 weeks	BMI will be calculated: weight (kg)/ height (cm)\^2
Katz Activities of Daily Living	Change from baseline to 12 weeks	A standardized, validated tool that asks about independence in bathing, dressing, toileting, transferring, continence and feeding.
Quality of Life	Change from baseline to 12 weeks	EQ5D, self-reported quality of life tool

Trial Locations

Locations (1)

Hospital Clinico Universitario; 🇪🇸 Valladolid, Spain