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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Knee Arthritis; Hip Arthritis
• Intervention / Treatment: Dietary supplement: Whey protein and Collagen supplementation

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Herlev/Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Collagen; Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days	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.
EXPERIMENTAL: Whey Protein; Participants of this arm are going to consume 30 g of whey protein daily for 30 days	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Handgrip strength	Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage	Weekly for 30 days
Extension strength of quadriceps femoris	Measured in amounts of repetitions of 0.5 or 1.0 kg.	Weekly for 30 days
Life quality	Measured trough EuroQol-5D-5L	Weekly for 30 days
Difference in functional ability (NMS)	Assessed by New mobility score	Weekly 30 days
Difference in Chair stand test	Measured by amount of repetitions	Weekly for 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability of the protein supplementation	Assessed on a scale from 1-5	30 days
Consistency of the protein supplementation	Assessed on a scale from 1-5	30 days
Compliance of the protein supplementation intake	Assessed trough a weekly form, which the participants will fill in	Weekly for 30 days
Rapported side effects	Participants will be informed to rapport if they experience any side effects throughout the intervention	30 days

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2020
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): August 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; Hip Arthroplasty; Whey protein; Collagen
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Arthritis; Sarcopenia
• Other Study ID Numbers: ValleKollagen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No