An Oral Nutritional Supplement Study in Older Malnourished Spanish Population
A Prospective, Observational Study, of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished Spanish Population
1 other identifier
observational
224
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedApril 1, 2015
March 1, 2015
1.4 years
March 27, 2015
March 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Body Weight
Change from baseline to 12 weeks
Secondary Outcomes (3)
Body Mass Index (BMI)
Change from baseline to 12 weeks
Katz Activities of Daily Living
Change from baseline to 12 weeks
Quality of Life
Change from baseline to 12 weeks
Study Arms (1)
Nutritional Supplement
Free living and residing and nursing home malnourished patients
Interventions
Eligibility Criteria
Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
Hospital Clinico Universitario
Valladolid, 47005, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rebeca Sanz Barriuso, RD, PharmD
Abbott Nutrition
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 1, 2015
Study Start
June 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
April 1, 2015
Record last verified: 2015-03