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

June 22, 2022 updated by: Abbott Nutrition

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Leon
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28040
        • Hospital Universitario Clínico San Carlos
      • Plasencia, Spain, 10600
        • Hospital Virgen del Puerto
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Nuestra Señora 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 12
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
Baseline to Week 12
Short Physical Performance Battery (SPPB)
Time Frame: Week 12
Timed assessments of balance, gait speed and chair standing; Scaled in the negative direction
Week 12
Compliance with Nutritional Supplement
Time Frame: Baseline to Week 12
Subject completed consumption dairy
Baseline to Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Chemistries - Chemistry Profile
Time Frame: Baseline to Week 12
Blood chemistries collected per standard of care
Baseline to Week 12
Blood Chemistries - Hematology Profile
Time Frame: Baseline to Week 12
Hematology blood chemistries collected per standard of care
Baseline to Week 12
Blood Chemistries - Lipid Panel
Time Frame: Baseline to Week 12
Lipid panel blood chemistries collected per standard of care
Baseline to Week 12
Body Mass Index
Time Frame: Baseline to Week 12
BMI calculated Weight (kg)/Height (m)2
Baseline to Week 12
Length of Stay in Hospital
Time Frame: Week 12
Information collected for hospital admission and discharge dates
Week 12
Healthcare provider satisfaction questionnaire
Time Frame: Week 12
HCP completed questionnaire; 3 to 5 category responses scaled in negative direction
Week 12
Subject satisfaction questionnaire
Time Frame: Week 12
Subject completed questionnaire; Responses 1 to 10 scaled in the positive direction
Week 12
Medication Use
Time Frame: Baseline to Week 12
Medications prescribed
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Maria Camprubi, PhD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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