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

Not Applicable

Completed

• Conditions: Sarcopenia; Knee Arthritis; Hip Arthritis
• Interventions: Dietary Supplement: Whey protein and Collagen supplementation

• Registration Number: NCT04496856
• Lead Sponsor: University of Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-10
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagen	Whey protein and Collagen supplementation	Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days
Whey Protein	Whey protein and Collagen supplementation	Participants of this arm are going to consume 30 g of whey protein daily for 30 days

Primary Outcome Measures

Name	Time	Method
The difference in fat free mass	Weekly for 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Difference in Chair stand test	Weekly for 30 days	Measured by amount of repetitions
Handgrip strength	Weekly for 30 days	Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage
Extension strength of quadriceps femoris	Weekly for 30 days	Measured in amounts of repetitions of 0.5 or 1.0 kg.
Difference in functional ability (NMS)	Weekly 30 days	Assessed by New mobility score
Redness and infection	Weekly for 30 days	The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.
Life quality	Weekly for 30 days	Measured trough EuroQol-5D-5L
Wound healing	Weekly for 30 days	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.

Trial Locations

Locations (1)

Herlev/Gentofte Hospital; 🇩🇰 Gentofte, Hellerup, Denmark