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

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition

• Study Type: Observational
• Enrollment (Actual): 310

Contacts and Locations

Study Locations

• Spain
  • Alcorcón, Spain, 28922
    • Hospital de Alcorcón
  • Gijón, Spain, 33202
    • Hospital Cruz Roja Gijón
  • Guadalajara, Spain, 19002
    • Hospital Universitario de Guadalajara
  • Huelva, Spain, 21080
    • Hospital Infanta Elena
  • Las Palmas, Spain, 35010
    • Hospital Universitario de Gran Canaria Doctor Negrín
  • León, Spain, 24071
    • Complejo Asistencial Universitario de León
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Plasencia, Spain, 10600
    • Hospital Virgen del Puerto
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Nuestra Senora de Candelaria
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen De Valme
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Valladolid, Spain, 47003
    • Hospital Clínico Universitario de Valladolid
  • Ávila, Spain, 50003
    • Complejo Asistencial de Ávila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include older men and women who are free living (outpatient) or residing in a nursing home, who meet all enrollment criteria. Subjects will be recruited by the investigator(s) from each study site.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Status	Measured by the Mini Nutritional Assessment (MNA) 18 questions; 30 total point scale where lower number indicates risk of malnutrition	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index of Activities of Daily Living	Subject completed assessment of 10 functions; Sum of scores range from 0-100 scaled in positive direction	Baseline to Week 12
Functional Ambulation Classification Scale (FAC)	6-level scale assesses ambulation status; scaled in the positive direction; the higher level indicates greater ambulation	Baseline to Week 12
Short Physical Performance Battery (SPPB)	Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction	Week 12
Compliance with Nutritional Supplement	Subject completed consumption dairy	Baseline to Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Chemistries - Chemistry Profile	Blood chemistries collected per standard of care	Baseline to Week 12
Blood Chemistries - Hematology Profile	Hematology blood chemistries collected per standard of care	Baseline to Week 12
Blood Chemistries - Lipid Panel	Lipid panel blood chemistries collected per standard of care	Baseline to Week 12
Body Mass Index	BMI calculated Weight (kg)/Height (m)2	Baseline to Week 12
Length of Stay in Hospital	Information collected for hospital admission and discharge dates	Week 12
Healthcare provider satisfaction questionnaire	HCP completed questionnaire; 3 to 5 category responses scaled in negative direction	Week 12
Subject satisfaction questionnaire	Subject completed questionnaire; Responses 1 to 10 scaled in the positive direction	Week 12
Medication Use	Medications prescribed	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Maria Camprubi, PhD, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Nutrition Disorders; Femoral Fractures; Hip Injuries; Hip Fractures; Malnutrition
• Other Study ID Numbers: DA20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No