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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02404987

Enrollment

224

Registered

2015-04-01

Start date

2014-06-30

Completion date

2015-11-30

Last updated

2015-04-01

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

Conditions

Malnutrition

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.

Interventions

OTHERNutritional Supplement

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Body Weight	Change from baseline to 12 weeks

Secondary

Measure	Time frame	Description
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

Countries

Spain

Contacts

Primary ContactKristen DeLuca, MS, RD

kristen.deluca@abbott.com614-624-5455

Outcome results

None listed

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