Improving muscle strength and quality of life in older patients with nutritional supplements
Effect of Oral Nutritional Supplements on Muscle Strength in Older Patients At Nutritional Risk Discharged with a Rehabilitation Plan
This study is testing if giving nutritional drinks to older patients after they leave the hospital can help them get stronger and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT05556876 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of oral nutritional supplements on elderly patients who are discharged with a rehabilitation plan. Participants will be randomly assigned to either receive nutritional drinks twice daily for 12 weeks or to a control group with no additional intervention. Data will be collected at discharge, after 6 weeks via phone, and after 12 weeks during a home visit, focusing on muscle strength, muscle mass, quality of life, and other health indicators. The study aims to include 124 patients at nutritional risk to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 65 and older who are at nutritional risk and have a rehabilitation plan upon discharge.
Not a fit: Patients with active cancer, renal insufficiency, or cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and quality of life for older patients at nutritional risk.
How similar studies have performed: Previous studies have shown positive outcomes with nutritional interventions in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herlev
- Herlev and Gentofte hospital — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Anne Marie Beck, PhD
- Email: anne.marie.beck@regionh.dk
- Phone: 38682387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.