An Oral Nutritional Supplement Study in Older Malnourished Spanish Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

224 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nutritional Supplement

Free living and residing and nursing home malnourished patients

Nutritional Supplement

Intervention Type OTHER

Interventions

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Nutritional Supplement

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No