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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05556876
Other study ID # version2/30.03.2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date March 1, 2026

Study information

Verified date December 2023
Source Herlev and Gentofte Hospital
Contact Anne Marie Beck, PhD
Phone 38682387
Email anne.marie.beck@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date March 1, 2026
Est. primary completion date November 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Protein omega-3
An oral supplement with a high content of protein and with essential fatty acids

Locations

Country Name City State
Denmark Herlev and Gentofte hospital Herlev

Sponsors (2)

Lead Sponsor Collaborator
Herlev and Gentofte Hospital Nutricia, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leg Muscle strength Chair stand change from baseline to 12 weeks follow-up
Secondary Hand grip Muscle strength Hand grip strength change from baseline to 12 weeks follow-up
Secondary Health related quality of life EQ5D5L questionnaire with five dimensions and five level of answers. To be converted to an index were -1 is worst and 1 is best health related quality of life Change from baseline 12 weeks follow-up
Secondary Activities of daily living Functional recovery score The eleven-item questionnaire is comprised of three main components: basic activities of daily living (BADL) assessed by four items, instrumental activities of daily living (IADL) assessed by six items, and mobility assessed by one item. Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent. Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100 percent Change from baseline to 12 weeks follow-up
Secondary energy and protein intake 24 hour dietary recall at 12 weeks follow-up
Secondary Appetite Simplified Nutritional Appetite Questionnaire [SNAQ. The questionnaire results in a score ranging from 5 to 20, where 5 is lowest appetite Change from baseline to 12 week follow-up
Secondary Muscle mass Bio impedance measurement of body composition Change from baseline to 12 week follow-up
Secondary Frailty The "FRAIL" Questionnaire includes questions concerning Fatigue, Resistance (capability of stair climbing),Aerobic( walking distance), Illnesses (multi morbidity), and Loss of weight. Physical frailty, pre-frailty and non-frailty is defined as having 3 or greater; 1 or 2 or no factors respectively Change from baseline to 12 weeks follow-up
Secondary initiation and completion of rehabilitation questionnaire were participants can document their attendance to exercise rehabilitation and reasons for not attending. at 12 week follow-up
Secondary compliance to oral nutritional supplements a diary were participants can register their intake of supplements and eventual side effects. A compliance of 100% is aimed for as optimal at 12 weeks follow-up
Secondary readmissions number, length and percentage of readmissions after discharge will be calculated 38 weeks after discharge
Secondary mortality number and percentage of mortality after discharge will be calculated 38 weeks after discharge
Secondary inflammation blood measurements of CRP and omega-3 fatty acids change from baseline to 12 weeks follow-up
Secondary vitamin D status blood measurements of vitamin D change from baseline to 12 weeks follow-up
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