Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients

Sarcopenia Clinical Trial

Official title:

The Effects of Whey Protein and Collagen on Fat Free Mass, Muscle Strength and Wound Healing in Elderly Patients Undergoing Elective Knee- or Hip Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496856
• Other study ID #: ValleKollagen
• Status: Completed
• Phase: N/A
• Start date: May 10, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the effect of whey protein and collagen on fat free mass, muscle strength, functional ability, wound healing and life quality in elderly patients undergoing elective knee- or hip surgery (defined as elective knee- or hip arthroplasty). The patients are admitted at the department of Orthopaedic Surgery at Herlev Gentofte Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65+ years
• Scheduled elective knee- or hip surgery
• Must be able to understand and speak danish
• Must be able to chew and swallow food with a regular consistency
• Must be able to consume the assigned protein supplementation
• Must be able to consent participation

Exclusion Criteria:

• Vegan
• Demensia
• Critical complications to the surgery which prevents the patient from participating in the rehabilitation program
• Plasma-creatinin above 250 micromol/L
• Palliative patients
• Known intolerance of whey protein and/or collagen
• Patients with a pacemaker

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Knee Arthritis
• Sarcopenia

Intervention

Dietary Supplement:
• Whey protein and Collagen supplementation
Participants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored.

Locations

Country	Name	City	State
Denmark	Herlev/Gentofte Hospital	Gentofte	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Palatability of the protein supplementation	Assessed on a scale from 1-5	30 days
Other	Consistency of the protein supplementation	Assessed on a scale from 1-5	30 days
Other	Compliance of the protein supplementation intake	Assessed trough a weekly form, which the participants will fill in	Weekly for 30 days
Other	Rapported side effects	Participants will be informed to rapport if they experience any side effects throughout the intervention	30 days
Primary	The difference in fat free mass	The outcome will be monitored through BIA and the development of fat free mass in the operated leg will be compared to the development of fat free mass in the non-operated leg.	Weekly for 30 days
Secondary	Wound healing	The amount of days until the wound is healed (defined as: the epithelium is covered without crust). This will be monitored trough pictures and assessed on a scale from 1-5 by a masked doctor.	Weekly for 30 days
Secondary	Redness and infection	The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.	Weekly for 30 days
Secondary	Handgrip strength	Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage	Weekly for 30 days
Secondary	Extension strength of quadriceps femoris	Measured in amounts of repetitions of 0.5 or 1.0 kg.	Weekly for 30 days
Secondary	Life quality	Measured trough EuroQol-5D-5L	Weekly for 30 days
Secondary	Difference in functional ability (NMS)	Assessed by New mobility score	Weekly 30 days
Secondary	Difference in Chair stand test	Measured by amount of repetitions	Weekly for 30 days