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Completed

NCT Number: NCT03882944

An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Alcorcón, Alcorcón, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study.
  • Subject is considered malnourished, or is at risk for malnutrition
  • Subject conforms to the requirements set forth on the study product label.
  • Subject has an estimated, or measured, glomerular filtration rate >30ml/min/1.73m2 (MDRD equation).
  • Subject has been elected for hip fracture surgery and is within three days since surgery.
  • The study physician determines the subject is fit to participate.
  • Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional.
  • After surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay < 15 days.

Exclusion criteria

  • Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol.
  • Subject has active cancer and the study physician determines the subject is not suitable for the study.
  • Subject has uncontrolled diabetes.
  • Subject is known to be allergic or intolerant to any ingredient found in the study product.
  • Participation in another study that has not been approved as a concomitant study.

Treatment and study plan

Primary outcomes

  1. Nutritional Status

    Time frame: Baseline to Week 12

    Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition

Secondary outcomes

  1. Barthel Index of Activities of Daily Living

    Time frame: Baseline to Week 12

    Subject completed assessment of 10 functions; Sum of scores range from 0-100 scaled in positive direction

  2. Functional Ambulation Classification Scale (FAC)

    Time frame: Baseline to Week 12

    6-level scale assesses ambulation status; scaled in the positive direction; the higher level indicates greater ambulation

  3. Short Physical Performance Battery (SPPB)

    Time frame: Week 12

    Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction

  4. Compliance with Nutritional Supplement

    Time frame: Baseline to Week 12

    Subject completed consumption dairy

Other outcomes

  1. Blood Chemistries - Chemistry Profile

    Time frame: Baseline to Week 12

    Blood chemistries collected per standard of care

  2. Blood Chemistries - Hematology Profile

    Time frame: Baseline to Week 12

    Hematology blood chemistries collected per standard of care

  3. Blood Chemistries - Lipid Panel

    Time frame: Baseline to Week 12

    Lipid panel blood chemistries collected per standard of care

  4. Body Mass Index

    Time frame: Baseline to Week 12

    BMI calculated Weight (kg)/Height (m)2

  5. Length of Stay in Hospital

    Time frame: Week 12

    Information collected for hospital admission and discharge dates

  6. Healthcare provider satisfaction questionnaire

    Time frame: Week 12

    HCP completed questionnaire; 3 to 5 category responses scaled in negative direction

  7. Subject satisfaction questionnaire

    Time frame: Week 12

    Subject completed questionnaire; Responses 1 to 10 scaled in the positive direction

  8. Medication Use

    Time frame: Baseline to Week 12

    Medications prescribed

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

A Prospective, Observational Study of the Effect of a High Calorie and Protein Oral Nutritional Supplement, in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 20, 2019
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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