Back to resultsEffects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients
Primary Purpose
Hip Arthritis, Sarcopenia, Knee Arthritis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Whey protein and Collagen supplementation
Sponsored by
About this trial
This is an interventional supportive care trial for Hip Arthritis focused on measuring Hip Arthroplasty, Collagen, Whey protein, Knee Arthroplasty
Eligibility Criteria
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
Sites / Locations
- Herlev/Gentofte Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Collagen
Whey Protein
Arm Description
Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days
Participants of this arm are going to consume 30 g of whey protein daily for 30 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Redness and infection
The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.
Handgrip strength
Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage
Extension strength of quadriceps femoris
Measured in amounts of repetitions of 0.5 or 1.0 kg.
Life quality
Measured trough EuroQol-5D-5L
Difference in functional ability (NMS)
Assessed by New mobility score
Difference in Chair stand test
Measured by amount of repetitions
Full Information
NCT ID
NCT04496856
First Posted
July 29, 2020
Last Updated
September 28, 2021
Sponsor
University of Copenhagen
Collaborators
Herlev and Gentofte Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04496856
Brief Title
Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Herlev and Gentofte Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthritis, Sarcopenia, Knee Arthritis
Keywords
Hip Arthroplasty, Collagen, Whey protein, Knee Arthroplasty
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagen
Arm Type
Experimental
Arm Description
Participants of this arm are going to consume 30 g of collagen peptides daily for 30 days
Arm Title
Whey Protein
Arm Type
Experimental
Arm Description
Participants of this arm are going to consume 30 g of whey protein daily for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein and Collagen supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference in fat free mass
Description
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.
Time Frame
Weekly for 30 days
Secondary Outcome Measure Information:
Title
Wound healing
Description
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.
Time Frame
Weekly for 30 days
Title
Redness and infection
Description
The redness and infection around the wound assessed on a scale from 1-5 by a masked doctor through pictures.
Time Frame
Weekly for 30 days
Title
Handgrip strength
Description
Handgrip strength measured by a handdynanometer (SAEHAN) in kg and percentage
Time Frame
Weekly for 30 days
Title
Extension strength of quadriceps femoris
Description
Measured in amounts of repetitions of 0.5 or 1.0 kg.
Time Frame
Weekly for 30 days
Title
Life quality
Description
Measured trough EuroQol-5D-5L
Time Frame
Weekly for 30 days
Title
Difference in functional ability (NMS)
Description
Assessed by New mobility score
Time Frame
Weekly 30 days
Title
Difference in Chair stand test
Description
Measured by amount of repetitions
Time Frame
Weekly for 30 days
Other Pre-specified Outcome Measures:
Title
Palatability of the protein supplementation
Description
Assessed on a scale from 1-5
Time Frame
30 days
Title
Consistency of the protein supplementation
Description
Assessed on a scale from 1-5
Time Frame
30 days
Title
Compliance of the protein supplementation intake
Description
Assessed trough a weekly form, which the participants will fill in
Time Frame
Weekly for 30 days
Title
Rapported side effects
Description
Participants will be informed to rapport if they experience any side effects throughout the intervention
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Herlev/Gentofte Hospital
City
Gentofte
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Whey and Collagen on FFM, Muscle Strength and Wound Healing in Elderly Surgical Patients
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