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NCT05556876 | Recruiting | Nutritional Risk

Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation Plan
Sponsor:

Herlev and Gentofte Hospital

Information provided by (Responsible Party):

Anne Marie Beck

Brief Summary:

The purpose of the study is to investigate whether an extra intake of energy and protein in the form of nutritional drinks twice a day for 12 weeks can improve muscle strength, muscle mass, quality of life and the implementation of rehabilitation in elderly patients at nutritional risk who are discharged to municipal rehabilitation

Condition or disease

Nutritional Risk

Rehabilitation

Oral Nutritional Supplements

Intervention/treatment

Protein omega-3

Phase

Not Applicable

Detailed Description:

The study is a single-blind randomised study where the subjects will be randomly divided into two groups. A group that must consume nutritional drinks in connection with their rehabilitation and a group that must do nothing extra. Based on a statistical power calculation, we will include a total of 124 patients. In connection with the experiment, different data will be collected three times, in connection with the discharge from the hospital, after 6 weeks via the telephone and after 12 weeks. During a home visit. Here, various questionnaires will have to be answered and data on muscle strength and muscle mass will be collected. Further CRP, vitamin D status and EPA/DHA content in blood will be assessed. In addition, data is collected from the patient's medical record about e.g. readmissions}}

Study Type : Interventional
Estimated Enrollment : 124 participants
Masking : Single
Masking Description : two set of files
Primary Purpose : Treatment
Official Title : Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients at Nutritional Risk Discharged With a Rehabilitation Plan
Actual Study Start Date : December 1, 2023
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : March 1, 2026
Arm Intervention/treatment

Active Comparator: Intervention

the intervention group will be provided with oral nutritional supplements for 12 weeks after discharge

No Intervention: Control

the control group will receive usual care after discharge
Ages Eligible for Study: 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Men and women aged ≥ 65 years old
  • Independent stand function
  • Able to speak and understand Danish
  • At nutritional risk according to NRS-2002
  • (Expected to be) discharged with a new rehabilitation plan
  • Admitted to the medical and orthopaedic departments of Gentofte or Herlev Hospital
Exclusion Criteria
  • Active cancer
  • Renal insufficiency (eGFR < 27 mL/min/1.73m2)
  • Cognitive impairment (not able to comprehend the purpose of the study/give informed consent)
  • Terminal disease
  • Exclusively receiving texture modified food, enteral or parenteral nutrition
  • Planning to lose weight/go on a special diet
  • Planned transfer to other hospitals/departments
  • Pacemaker/other implanted electrical stimulants (due to Bio-Impedance Analysis (BIA)
  • Taking fish-oil supplements as a medical prescription due to hypertriglyceridemia
  • Taking fish-oil supplements for other reasons and do not wish to stop this during the study period
Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation Plan

Location Details

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Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation Plan

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Denmark,

Herlev and Gentofte hospital

Here live, Denmark, 2730