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

Completed

• Conditions: Malnutrition

• Registration Number: NCT03882944
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Study Start: 2020-02-20
• Primary Completion: 2021-12-15
• Study Completion: 2022-03-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nutritional Status	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 Outcome Measures

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

Trial Locations

Locations (17)

Hospital Infanta Elena; 🇪🇸 Huelva, Spain

Hospital de Alcorcón; 🇪🇸 Alcorcón, Spain

Hospital Universitario de Guadalajara; 🇪🇸 Guadalajara, Spain

Hospital Universitario de Gran Canaria Doctor Negrin; 🇪🇸 Las Palmas, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Universitario Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Virgen del Puerto; 🇪🇸 Plasencia, Spain

Hospital Universitario De Salamanca; 🇪🇸 Salamanca, Spain

Hospital Nuestra Señora de Candelaria; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Complejo Asistencial de Avila; 🇪🇸 Ávila, Spain

Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain

Hospital Cruz Roja Gijón; 🇪🇸 Gijón, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain